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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

410 Study Matches

MT2023-30: A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

The purpose of this study is to test the safety of FT825 at different doses and to understand the way the body processes and responds to FT825. The study will also find out what effects FT825, when given with or without a monoclonal antibody (cetuximab) and different chemotherapy regimens, have on cancer. FT825 is a type of cell product made up of “T cells.” T cells are part of your immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells.

Manish Patel
18 years and over
This study is NOT accepting healthy volunteers
SITE00002088
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Inclusion Criteria:

• diagnosis locally advanced or metastatic cancer
• cancer that is not amenable to curative therapy, with prior therapies defined by specific tumor types
• restricted from strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• active central nervous system (CNS) involvement by cancer -active bacterial, fungal, or viral infections
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Metastatic Cancer, Solid Tumor Cancer
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MT2015-29 : Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Adult Unrelated Donor for the Treatment of Hematological Disorders

Punita Grover
Up to 60 years old
STUDY00001087
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Inclusion Criteria:
Age: ≤ 60 years of age Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70 Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian) Adequate Organ Function: Renal: Creatinine <2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR. Hepatic: Bilirubin, AST, alkaline phosphatase <4 times the upper limit of institutional normal Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, > 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of >95% on room air Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Other
Inclusion Criteria:
Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol. Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse. Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients > 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk. Favorable risk AML is defined as having one of the following: t(8,21) without cKIT mutation inv(16) or t(16;16) without cKIT mutation Normal karyotype with mutated NPM1 and wild type FLT-ITD Normal karyotype with double mutated CEBPA Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation Very high risk pediatric patients with AML: Patients <21 years, however, are eligible with (M2 marrow) with < 25% blasts in marrow after having failed one or more cycles of chemotherapy. Acute lymphoblastic leukemia (ALL)/lymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL. High risk ALL is defined as having one of the following: Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1 30 years of age or older at diagnosis White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis CNS leukemia involvement during the course of disease Slow cytologic response (>10% lymphoblasts in bone marrow on Day 14 of induction therapy) Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy Very high risk pediatric patients with ALL: patients <21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission. Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors. Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission Myeloproliferative Neoplasms/Myelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be <10% by bone marrow aspirate morphology. Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be < 10% by a representative bone marrow aspirate morphology. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant. Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+. Diffuse large Cell NHL > CR/> PR: Patients in CR/PR with initial short remission (<6 months) are eligible, or those who have failed/or are not eligible for autologous transplant. Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year. Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy. Juvenile myelomonocytic leukemia Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR. MRD positive leukemia (AML, ALL or accelerated/blast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status. Natural Killer Cell Malignancies Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.
Exclusion Criteria:
Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens) CML in blast crisis Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy. Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression. Active central nervous system malignancy if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant Active HIV infection or known HIV positive serology active uncontrolled infection Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
Clinics and Surgery Center (CSC)
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Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma: Big Ten Cancer Research Consortium BTCRC-HN17-111

We are looking at the effectiveness of adding an immunotherapy drug, pembrolizumab, to usual treatment for people who have salivary gland cancer that can’t be treated with surgery or radiation. The cancer must be androgen receptor positive.

Manish Patel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00004710
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Inclusion Criteria:

• at least 18 years old
• locally advanced, recurrent, or metastatic salivary gland carcinoma that is not amenable to curative surgery or radiation
• tumor is androgen receptor-positive
• unable to do physically strenuous activity but can walk and is able to do work of a light nature, such as house work or office work
• prior chemotherapy, radiation, or surgery as part of curative intent therapy are allowed
• any number of prior lines of systemic therapy are permitted as long as it did not include anti-androgen therapy or immune checkpoint blockade
• men and women of child bearing age must agree to use contraception during the treatment period and for at least 8 months after the last dose of study treatment
• contact study staff for additional requirements
Exclusion Criteria:

• received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
• received prior androgen deprivation therapy
• pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the first visit through 120 days after the last dose of trial treatment.
• additional cancer that is progressing or has required active treatment within the past 2 years
• contact study staff for additional exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Salivary Gland Carcinoma
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2020IS043; MT2020-06; A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF JSP191 FOR HEMATOPOIETIC CELL TRANSPLANTATION CONDITIONING TO ACHIEVE ENGRAFTMENT AND IMMUNE RECONSTITUTION IN SUBJECTS WITH SCID

This study is looking at whether giving a new type of experimental medicine, called JSP191, can prepare the body to help the stem cell transplant work better, so the immune system can grow and fight infections. The study doctor and Sponsor also want to see how safe and well tolerated this experimental medicine is. They will study whether it is safe to give to patients and look at how much medication to give and what side effects may occur. During this study, the optimal dose of JSP191 will be determined and additional patients will be enrolled in this study using that dose level.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
STUDY00010559
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Inclusion Criteria:

• at least 3 months old
• diagnosis of typical Severe Combined Immunodeficiency (SCID)
• patient with human leukocyte antigen (HLA) matched related or unrelated donors
Exclusion Criteria:

• acute or uncontrolled infections
• patients receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
• patients with active malignancies
• active Graft-versus-host disease (GVHD) within 6 months prior to enrollment, or on immunosuppressive therapy for GVHD
Immune Diseases, Rare Diseases
SCID, Severe combined immunodeficiency
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A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naive Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

The investigational therapy in this study is referred to as Restorative Microbiota Therapy (RMT). It is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth. The donor stool samples are rigorously tested for harmful bacteria and viruses before processing. There is scientific evidence to suggest that RMT might make immunotherapy more effective. The primary goal of the study is to test if RMT makes durvalumab + tremelimumab treatment with chemotherapy more effective to control lung cancer.

Amit Kulkarni
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007800
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Inclusion Criteria:

• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Cancer, Respiratory System
Clinics and Surgery Center (CSC), Adenocarcinoma of Lung, Lung Cancer
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MT2022-56: A Phase I Study of FT576 as Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma

The purpose of this study is to test the safety of FT576 at different doses and schedules and to understand the way the body processes and responds to FT576. The study will also find out what effects FT576, when given alone (also called monotherapy) or in combination with an anti-cancer drug (called a monoclonal antibody), may have on you and your cancer. FT576 is a type of cell product made up of “natural killer” or NK cells. NK cells are a type of immune blood cell that are known to attack cancer cells.

Aimee Merino
18 years and over
This study is NOT accepting healthy volunteers
SITE00001809
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Inclusion Criteria:

• diagnosis of multiple myeloma after 3 or more previous treatments
• able to complete activities of daily living with minimal help
Exclusion Criteria:

• history of significant heart disease
• low red or white blood counts
• abnormal liver function tests
Cancer
Multiple Myeloma, Myeloma, Clinics and Surgery Center (CSC)
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HM2021-31: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

This protocol aims to characterize the safety and tolerability of loncastuximab tesirine in combination with gemcitabine, lenalidomide, polatuzumab vedotin, or umbralisib, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for any of the combinations in subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This project aims to address the resistance mechanisms to single agent therapies and enhance efficacy by engaging different targets, in synergistic or additive manner.

Marie Hu
18 years and over
STUDY00015805
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Inclusion Criteria:
Male or female participant aged 18 years or older Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-NHL (2016 World Health Organization classification) who have failed, or been intolerant to any approved therapy and had received at least two systemic treatment regimens in dose-escalation part; and at least one systemic treatment regimen in dose-expansion part DLBCL (including transformed diseases, but for Arms E and F, including transformed FL only) HGBCL FL MZL MCL (for Arm C only) BL (for Arm C only) Life expectancy of at least 24 weeks according to Investigator's judgement Need of systemic treatment for any of the listed indications as assessed by the investigator, including indolent B-NHLs (e.g. FL and MZL) Measurable disease as defined by the 2014 Lugano Classification Availability of formalin-fixed paraffin-embedded tumor tissue block ECOG performance status 0 to 2 Adequate organ function Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent the first dose until at least 7 months after the last dose of loncastuximab tesirine. Men must refrain from donating sperm during this same period. For the arm that includes glofitamab, WOCBP must agree to use contraceptive methods that result in a failure of <1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 18 months after pretreatment with obinutuzumab. For the arm that includes mosunetuzumab, WOCBP must agree to use contraceptive methods that result in a failure of <1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable).
Exclusion Criteria:
Known history of hypersensitivity resulting in treatment discontinuation to or positive serum human ADA to a CD19 antibody Previous therapy with loncastuximab tesirine Previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab (applied to relevant arm and/or cohort of the specific drug administered) Participants who received previous treatment of polatuzumab vedotin containing regimen will be excluded from Arm C Participants who received previous treatment of glofitamab containing regimen will be excluded from Arm E Participants who received previous treatment of mosunetuzumab containing regimen will be excluded from Arm F Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1 D1) Human immunodeficiency virus (HIV) seropositive Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load History of confirmed progressive multifocal leukoencephalopathy History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH) Lymphoma with active central nervous system (CNS) involvement at the time of screening, including leptomeningeal disease Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath) Breastfeeding or pregnant Significant medical comorbidities Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drugs (C1 D1), except shorter if approved by the Sponsor Live vaccine within 4 weeks prior to C1D1 Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from acute non-hematologic toxicity (Grade ≤2 alopecia) due to previous therapy prior to screening Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary Extra Exclusion Criteria for Arms E (includes glofitamab) and F (includes mosunetuzumab) Note: as applicable, the arm-specific exclusion criteria may supersede the general ones, such as stem cell transplant. Prior allogeneic stem cell transplant and solid organ transplant Autologous stem cell transplant within 100 days prior to C1D1 History of CNS lymphoma or leptomeningeal infiltration Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease Known active infection, reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within four weeks prior to C1D1 Active or history of autoimmune disease or immune deficiency, including but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain Barré syndrome, or multiple sclerosis, with certain exceptions Prior treatment with anti-cancer/lymphoma targeted therapies (e.g., tyrosine kinase inhibitors, systemic immunotherapeutic/immunostimulating agents, including, but not limited to, cluster of differentiation 137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death protein 1 (PD1), and anti-programmed death ligand 1 (PDL1) therapeutic antibodies, radio-immunoconjugates, ADCs, immune/cytokines and monoclonal antibodies) or treatment with systemic immunosuppressive medication (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to C1D1, or anticipation of need for systemic immunosuppressive medication during study treatment, with certain exceptions Prior treatment with chimeric antigen receptor T-cell therapy within 30 days prior to C1D1 Toxicities from prior anti-cancer therapy including immunotherapy that did not resolve to ≤ Grade 1 with the exception of alopecia, endocrinopathy managed with replacement therapy and stable vitiligo Any history of immune-related Grade ≥3 AE with the exception of endocrinopathy managed with replacement therapy Ongoing corticosteroid use >25 mg/day of prednisone or equivalent within 4 weeks prior and during study treatment Administration of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after last dose of study treatment Extra Exclusion Criteria for Arm E (includes glofitamab) only. • Known history of hypersensitivity to obinutuzumab
Clinics and Surgery Center (CSC)
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A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104

This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.

Mark Schleiss
Up to 18 years old
This study is also accepting healthy volunteers
SITE00001871
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Inclusion Criteria:

• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
Exclusion Criteria:

• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
Children's Health, Infectious Diseases
CMV, cytomegalovirus, vaccine
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HM2022-48: A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia

This study is being performed to determine the safety and tolerability of ZN-c3 alone and the combination of ZN-c3 and ZN-d5 in Acute Myeloid Leukemia (AML). We want to identify the best doses of the study drugs and learn if either drug effects the blood levels of the other. We will also assess how effective the Study Drugs are in treating AML and explore whether certain aspects of AML can predict whether leukemia responds to the study drug(s).

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017682
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Inclusion Criteria:

• adults with Acute Myeloid Leukemia (AML) (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy
• able to walk and do selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs
• men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs
Exclusion Criteria:

• active central nervous system (CNS) involvement
• significant cardiovascular disease
• active hepatitis B or hepatitis C infection
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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A Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of INBRX-101 Compared to Plasma Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults with Alpha-1 Antitrypsin Deficiency (AATD) Emphysema (ELEVAATE)

This study is for people who have emphysema (a disorder where too much air collects deep in the lungs) that is caused by the lack of a protein called alpha-1 antitrypsin (AAT) in the body. A deficiency of AAT (AATD) can damage lung and liver if not treated. The goal of this study is to evaluate the safety and study the therapeutic effects of INBRX-101 in subjects with AATD emphysema when compared with current approved AATD therapy with A1PI, known as Zemaira®.

Ronald Reilkoff
18 years and over
This study is NOT accepting healthy volunteers
SITE00001985
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Inclusion Criteria:

• age 18 to 80
• diagnosis of Alpha 1-Antitrypsin Deficiency (AATD)
• symptoms of emphysema related to AATD
• currently not smoking
Exclusion Criteria:

• diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
• on waiting list for lung or liver transplant
• active cancers or has a history of cancer within past 5 years
• significant congestive heart failure
• additional exclusion criteria (study staff will review)
Breathing, Lung & Sleep Health
Clinics and Surgery Center (CSC), Alpha 1-Antitrypsin Deficiency, Emphysema
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A novel partial-enteral nutrition protocol to improve nutrition status of adult patients experiencing a Crohn's disease flare and starting new immunologic therapy

The purpose of this study is to evaluate if a partial enteral nutrition diet, with a pea protein plant-based oral nutrition supplement (ONS; Kate Farms Peptide 1.5), combined with the Inflammatory bowel disease - Anti-Inflammatory Diet (IBD-AID) improves the nutritional intake of adult patients experiencing a CD flare initiating immunologic therapy compared to standard of care. Standard of care for patients experiencing a CD flare is commonly characterized by prescription of a low fiber diet and either lack of oral nutrition supplementation or use of an animal protein based supplement.

Byron Vaughn
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013936
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Inclusion Criteria:

• 18 years and older
• diagnosis of moderate to severe Crohn's Disease (CD) as defined by physician
• starting new advanced therapy
Exclusion Criteria:

• short bowel syndrome
• ileostomy or colostomy
• use of pre or probiotic supplements within last 14 days
• active implanted medical devices (cardiac pacemaker, defibrillator)
• pregnancy
• other serious medical conditions (study staff will review)
Digestive & Liver Health
Crohn's Disease (CD)
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A feasibility study of topical cannabinoids for treatment of aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) in women with hormone receptor-positive breast cancer (CanAroma)

Aromatase inhibitors (AIs) are commonly used in treating hormone-positive breast cancer. Unfortunately, many patients receiving this treatment experience Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS), with symptoms like joint and bone pain and joint stiffness. The current therapies used to improve AIMSS symptoms have limited effectiveness and can cause their own side effects. In this research study, we are examining the feasibility of topical medical cannabis cream as a treatment option for AIMSS.

Anne Blaes, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00015727
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Inclusion Criteria:

• Stage I-III Breast Cancer.
• Currently taking Aromatase Inhibitor for at least 60 days.
• Aromatase Inhibitor use for no more than 48 months.
• Experiencing aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) symptoms.
• Minnesota resident
Exclusion Criteria:

• Currently using or has used cannabinoid products in the past 4 weeks.
• Active skin lesions on hands/wrists.
• Current or planned acupuncture treatments to hands and wrists.
• Plan to increase doses of other pain medications for improving AIMSS symptoms.
Cancer
aromatase inhibitors, hand, pain, stiffness, wrist
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A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome? followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species (OASIS)

This study will look at an investigational study drug, called olorofim, to determine how safe the study drug is, how well it is tolerated and whether it is effective compared to AmBisome® (a standard of care treatment) to treat invasive fungal disease (IFD). We expect that you will be in this research study for up to 18 weeks or just over 4 months.

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019092
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Inclusion Criteria:

• over 18 years old
• weigh more than 40 kg (88 pounds)
• Invasive Aspergillosis (IA) at any site
• require therapy with an antifungal agent other than a mold-active azole
Exclusion Criteria:

• women who are pregnant or breastfeeding
• known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
• people with chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis
• human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy
• certain heart and liver conditions (study staff will review)
Infectious Diseases, Respiratory System
Aspergillosis, IA, Invasive Aspergillosis (IA), Lung Infection
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Effectiveness of Screening and Decolonization of S. aureus to Prevent S. aureus Surgical Site Infections in Surgery Outpatients

The purpose of this study is to determine the most effective ways to get rid of Staph aureus on body surfaces before surgery. We will determine if the participants can effectively get rid of the bacteria with the simple application of various treatment methods assigned to them. We will study if these methods are useful and cost effective in preventing the infections after surgery.

Susan Kline, MD
18 years and over
This study is also accepting healthy volunteers
STUDY00019575
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Inclusion Criteria:

• at least 18 years old
• people who are scheduled for orthopedic, urology, neuro, otolaryngology, plastic and general surgery or OB/GYN surgery
• surgery is scheduled for at least 10 days following entry into the study
• have not taken antibiotics in the week before surgery
• will have a skin incision
Exclusion Criteria:

• surgery scheduled less than 10 days after the baseline cultures
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FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults with Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis (Aim 3)

The purpose of this study is to implement an intervention using a Follower, Action plan, and remote Monitoring (FAM) of glucose data to reduce severe hyperglycemia in adults with Type 1 Diabetes Mellitus at risk for diabetic ketoacidosis. You and your chosen “follower” (family member, caregiver, or friend) will be asked to attend 6 visits (in- person or remote) as a pair (“dyad”) with the study team that will last up to 30 minutes to 2 hours each across a span of 4 months.

Jacob Kohlenberg
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020104
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Inclusion Criteria:

• ages 18 to 65
• people with Type 1 Diabetes (T1DM) for at least 1 year
• HbA1C between 7.5% and 14.0%
• "Follower" (family member, friend, or caregiver who is at least 18 years old), willing to participate in the study and follow glucose data and has no self-reported cognitive impairment
Exclusion Criteria:

• active treatment with a sodium-glucose cotransporter-2 inhibitor or planning to start a sodium-glucose cotransporter-2 inhibitor in the next 6 months
• active cancer with the exception of non-melanoma skin cancer
• receiving hospice care
Diabetes & Endocrine
T1DM, Type 1 Diabetes
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Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia

The purpose of this study is to compare the effectiveness of megestrol alone, or combined with metformin, on the growth of Endometrial Intraepithelial Neoplasia (EIN). Participants will receive medication directed against EIN prior to the planned procedure (hysterectomy or progestin IUD placement). Women will receive either megestrol acetate pills by mouth twice a day for 3 to 5 weeks, or megestrol acetate and metformin pills twice a day by mouth for 3 to 5 weeks.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001945
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Inclusion Criteria:

• endometrial intraepithelial neoplasia (EIN) on an endometrial biopsy or dilation and curettage specimen
• willing to have surgery (hysterectomy) or non-surgical treatment with a progestin IUD
• if diabetic, blood glucose must be appropriately controlled as evidenced by a hemoglobin A1c of < 8.0 in the last three months prior to enrollment
• women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria:

• Current hormonal contraceptives or post-menopausal hormone replacement therapy, and uses of progestins (including progestin containing intrauterine device (there are exceptions, study staff will review)
• current use of metformin therapy. If previously used, it must be discontinued at least a year ago
• women who are pregnant or breast feeding
• history of pulmonary embolism, thrombotic stroke, arterial thrombosis or deep vein thrombosis
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Endometrial Carcinoma, endometrial intraepithelial neoplasia (EIN)
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ALX-HPP-501: An Observational,Longitudinal Prospective, Long-term Registry of Patients with Hypophosphatasia

This is a long-term registry is designed to collect data on hypophosphatasia (HPP) to better understand the condition and learn more about the disease, how patients feel about living with HPP and effect of HPP on the patients wellbeing and health. The study will look at participant’s medical records and health questionnaires about the health status of patients. This study collects observational data from clinical care and does not involve any treatment for HPP or administration of medication for HPP.

Kyriakie Sarafoglou
Not specified
This study is NOT accepting healthy volunteers
STUDY00004936
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Inclusion Criteria:

• confirmed diagnosis of HPP.
• documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, or a documented ALPL gene mutation.
• able to read and speak English
Exclusion Criteria:

• currently participating in an Alexion-sponsored clinical trial
Rare Diseases
HPP, Hypophosphatasia
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Geniculate Artery Embolization

Osteoarthritis (OA) is a leading cause of disability and chronic pain that reduces physical activity and daily activities. In this clinical research study, the goal is to learn more about geniculate artery (located in the knee) embolization (GAE) treatment to see if it will reduce pain as well as stiffness and difficulty performing daily activities caused by knee OA and if it can be performed safely.

Reza Talaie
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006202
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Inclusion Criteria:

• osteoarthritis of the one knee with symptoms that have not improved after at least 3 months of treatment such as PT, injection, medications,
• partial knee replacement and total knee arthroplasty are not currently options (may be in the future)
• 40-70 years of age
Exclusion Criteria:

• weight greater than 250 pounds
• smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• diabetic with A1C greater than 9%
• advanced peripheral arterial disease
Arthritis & Rheumatic Diseases, Bone, Joint & Muscle
Clinics and Surgery Center (CSC), Osteoarthritis
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Save the Bottoms!!!: Assessing the Gay Male Experience with Anal Cancer Prevention Strategies

The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.

Elliot Arsoniadis
18 years and over
This study is also accepting healthy volunteers
STUDY00017257
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Inclusion Criteria:

• 18 years of age or older
• AMAB (Assigned Male at Birth)
• Current resident of the U.S.
• Engage in receptive anal intercourse with male partners
• Fluent in English or Spanish
Cancer, Prevention & Wellness
Clinics and Surgery Center (CSC), Anal Cancer
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MT2013-31:Allogeneic Hematopoietic Cell Transplantation for Inherited Metabolic Disorders and Severe Osteopetrosis following Conditioning with Busulfan (Therapeutic Drug Monitoring), Fludarabine +/- ATG

To evaluate the ability to achieve high-level donor hematopoietic engraftment (defined as neutrophil recovery by Day +42 post-transplant and ≥ 80% donor cells on the myeloid fraction of peripheral blood at Day +100 post-transplant) using related and unrelated BM, PBSC, or UCB grafts following a reduced intensity conditioning regimen based on targeted-exposure busulfan, fludarabine +/- serotherapy in patients with inherited metabolic disorders and severe osteopetrosis.

Paul Orchard
Up to 55 years old
1406M51542
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Inclusion Criteria:
0 through 55 years of age Adequate graft available Adequate organ function Eligible Diseases: Mucopolysaccharidosis Disorders: MPS IH (Hurler syndrome) MPS II (Hunter syndrome) if the patient has no or minimal evidence of symptomatic neurologic disease but is expected to have a neurologic phenotype MPS VI (Maroteaux-Lamy syndrome) MPS VII (Sly syndrome) Glycoprotein Metabolic Disorders: Alpha mannosidosis Fucosidosis Aspartylglucosaminuria Sphingolipidoses and Recessive Leukodystrophies: Globoid cell leukodystrophy Metachromatic leukodystrophy Niemann-Pick B patients (sphingomyelin deficiency) Niemann-Pick C subtype 2 Peroxisomal Disorders: Adrenoleukodystrophy with cerebral involvement Zellweger syndrome Neonatal Adrenoleukodystrophy Infantile Refsum disease Acyl-CoA-Oxidase Deficiency D-Bifunctional enzyme deficiency Multifunctional enzyme deficiency Alpha-methylacyl-CoA Racmase Deficiency (AMACRD) Mitochondrial Neurogastrointestingal Encephalopathy (MNGIE) Severe Osteopetrosis (OP) Hereditary Leukoencephalopathy with axonal spheroids (HDLS; CSF1R mutation) Other Inherited Metabolic Disorders (IMD): Patients will also be considered who have other life-threatening, rare lysosomal, peroxisomal or other similar inherited disorders characterized by white matter disease or other neurologic manifestations for which there is rationale that transplantation would be of benefit, such as certain patients with Wolman's disease, GM1 gangliosidosis, I-cell disease, Tay-Sachs disease, Sandhoff disease or others. Voluntary written consent
Exclusion Criteria:
Pregnancy - menstruating females must have a negative serum or urine pregnancy test within 14 days of study treatment start Prior myeloablative chemotherapy exposure within 4 months of the start of conditioning on this protocol (patients excluded for this reason may be eligible for other institutional protocols) Uncontrolled bacterial, fungal or viral infections including HIV (including active infection with Aspergillus or other mold within 30 days)
Clinics and Surgery Center (CSC)
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Neptunia A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants receiving Standard of Care

This research is studying enpatoran (M5049) as a possible treatment for dermatomyositis (DM) and polymyositis (PM). The study will last for approximately 31 weeks (upto 9 study visits) and an additional optional 24 weeks (upto 5 study visits) if you agree to participate in the extension period for a total of up to 14 months (55 weeks). It will include approximately up to 3 telephone calls from the study center. The main activities in the study include: providing consent to participate, performing tests to check your health throughout the study (such as physical exams, electrocardiogram (ECG) testing, collection of urine and blood draws for laboratory testing), study drug dosing and recording relevant information in the study diary, and performing tests, completing questionnaires and assess signs and symptoms of your condition. This is a Phase 2a study. and it is anticipated that approximately 40 people will participate in this study.

David Pearson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001761
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Inclusion Criteria:
Adults with primarily diagnosed with Dermatomyositis (DM) or Polymyositis (PM)
Exclusion Criteria:
Diagnosis of myositis within 3 years of cancer
Dermatology (Skin, Hair & Nails)
Dermatomyositis (DM), Polymyositis (PM)
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MT2022-30: A double-blind, randomized, placebo-controlled, interventional, multicenter, phase llI clinical trial to investigate the safety and efficacy of ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs) on epidermolysis bullosa (EB)", allo-APZ2-EB-III

This is a study of an investigational drug (also known as the “study drug”) called allo-APZ2-OTS as a possible treatment for RDEB. The study drug contains allogeneic dermal ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs). These cells suppress inflammation and produce proteins that are important for wound healing. The study drug is expected to counteract local inflammation, improve wound healing and skin strength, and speed up wound closure.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
SITE00001758
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Inclusion Criteria:

• confirmed diagnosis of RDEB or JEB
• wound meeting the following criteria: 5-50 cm, present for at least 21 days and less than 9 months without signs of acute infection
• women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial
Exclusion Criteria:

• current cancer diagnosis including squamous cell carcinoma and basal cell carcinoma
• women who are pregnant or breast feeding
• clinically significant or unstable medical or mental health diagnosis (study staff will review)
Rare Diseases
EB, Epidermolysis Bullosa, RDEB
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COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00000151
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Inclusion Criteria:

• must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy
• see link to clinicaltrials.gov for additional inclusion criteria
Cancer
childhood cancer
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MT2017-17:T Cell receptor Alpha/Beta T Cell Depleted Hematopoietic Cell Transplantation in patients with Inherited Bone Marrow Failure (BMF) Disorders

The purpose of this study is to learn if removing the donor T cells from the donor product using this new method will be a better way to reduce the risk of GVHD. The benefit of removing these cells with this new method is that they will prevent GVHD without requiring drugs to suppress the immune system. Potentially, the immune system will recover from the transplant faster, which in turn will also lessen the risk of severe infections. As well, the patient will not have the other common undesired side effects of these immunosuppressive drugs.

Margaret MacMillan, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00003182
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Inclusion Criteria:

• up to 65 years of age
• have a diagnosis of Fanconi anemia
• have a suitable donor for peripheral blood cells
• women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment and 4 months after the transplant
• see link to clinicaltrials.gov for additional criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• cancer within previous 2 years
Blood Disorders, Rare Diseases
Clinics and Surgery Center (CSC), Fanconi Anemia, Myelodysplastic Syndromes, Severe Aplastic Anemia
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A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). (APPARENT)

To evaluate the efficacy and safety of iptacopan compared to placebo in patients with idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN)

Nattawat Klomjit
Not specified
This study is NOT accepting healthy volunteers
STUDY00020504
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Inclusion Criteria:

• 12 to 60 years old
• diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to starting the study for adults and within 3 years for adolescents
• must have a vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• have had cell or a solid organ transplantation, including kidney transplantation
• Body mass index (BMI) >38 kg/m2
• Body weight <35 kg (77 pounds)
• additional criteria that study staff will review
Clinics and Surgery Center (CSC), Glomerulonephritis, IC-MPGN
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Colleen Correll
Not specified
This study is NOT accepting healthy volunteers
1506M74443
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Inclusion Criteria:

• diagnosed with rheumatic disease prior to age 16 years for juvenile idiopathic arthritis (JIA)
• onset prior to age 19 years for all other rheumatic diseases
• younger than 21 years
Arthritis & Rheumatic Diseases, Cancer
juvenile idiopathic arthritis (JIA), pediatric rheumatic disease
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Hepatic Energy Fluxes, NASH, and Vertical Sleeve Gastrectomy

This study is looking at the liver function of people who have bariatric surgery. People who want to be in this trial must be obese, have abnormal liver function tests & prediabetes or type 2 diabetes. The study includes assistance with diet and exercise for a year after surgery.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006269
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Inclusion Criteria:

• age 18 to 67 years
• diagnosis of non-alcoholic steatohepatitis (NASH)
• Body Mass Index (BMI) 30.0-55.0 kg/m2
• willing to have surgical treatment and have insurance with no exclusion for obesity related treatments or management of obesity surgery complications
• live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Bariatric surgery, NASH, fatty liver, gastrectomy, gastric sleeve, sleeve, sleeve, VSG, weight loss
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MT2020-08 A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or &#8220;azer-cel&#8221;), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.

Joseph Maakaron
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009953
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Inclusion Criteria:

• diagnosis of Non-Hodgkin Lymphoma
• received at least 2, but no more than 7 prior chemotherapy-containing treatment regimens
• previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product
• restricted in strenuous activity but able to walk and able to carry out light work e.g., light house work, office work
• adequate bone marrow, renal, hepatic, pulmonary, and cardiac function (study staff will review)
Exclusion Criteria:

• prior or active CNS disease
• uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection
• active hepatitis B or hepatitis C
• any known uncontrolled cardiovascular disease
• contact study staff for additional exclusion criteria
Cancer
Non-Hodgkin Lymphoma
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A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants with Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma Protocol Number: CA224069 (RELATIVITY-069)

CA224069 is an open-label, Phase 1/2 clinical trial of relatlimab + nivolumab in children, adolescents and young adults with Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) and Non-Hodgkin Lymphoma (NHL). Part A will encompass safety and dose determination of relatlimab + nivolumab. Part B will be composed of an expansion cohort of cHL (Cohort 1) and an exploratory assessment in NHL (Cohort 2).

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00001545
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Inclusion Criteria:

• up to 30 years old
• pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard therapy prior to a definitive therapy e.g.high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT)
• participants with pathologically confirmed R/R NHL after failure or non-response to second line therapy, including but not limited to primary mediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL)
Exclusion Criteria:

• aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic lymphoma, and NK/T-cell lymphoma/leukemia
• prior autologous stem cell transplantation (HDCT/ASCT)
• see link to clinicaltrials.gov for additional exclusion criteria
Cancer
Hodgkin Disease, Lymphoma, Non-Hodgkin
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A Phase III, multicentre, randomised, double-blind, placebo-controlled study to investigate the efficacy, safety, and tolerability of COMP360 in participants with treatment-resistant depression

COMP360 is a human-made form of the naturally occurring chemical compound, psilocybin which may help in treating depression. In this research study we are comparing COMP360 to placebo, when administered with psychological support from a trained study therapist. Placebo is a substance that has no active medical ingredients and is commonly used in research studies to see if the investigational drug works better or is as safe as not taking anything at all.

Ziad Nahas
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020807
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Inclusion Criteria:

• diagnosis of major depression without psychotic features
• if the current major depressive episode is the first episode of depression, the length of the current episode must be at least 3 months and no more than 2 years
• have not responded to an adequate dose and duration of two, three, or four different medications to treat the current episode
• agree to discontinue all prohibited medications (study staff will review)
Exclusion Criteria:

• any additional major mental health diagnosis
• required psychiatric inpatient care in the past 12 months
• treatment with electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
• transcranial magnetic stimulation within the past six months
• in a psychological therapy program that will not remain stable for the duration of the study
Mental Health & Addiction
TRD, Treatment Resistant Depression
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