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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

COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00000295
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Inclusion Criteria:

• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
Exclusion Criteria:

• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
Cancer
Germ Cell Tumor, Malignant Germ Cell Tumor
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A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis

The purpose of this study is to learn about the safety and efficacy of PC945 when given in combination with the antifungal therapy that is normally given for this condition, also known as the standard of care (SoC). This study will also assess how PC945 is processed in the body (e.g., distributed, transformed, and removed) by measuring the levels of PC945 in your blood and lungs; this is called pharmacokinetics (PK).

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017568
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Inclusion Criteria:

• diagnosis of invasive pulmonary aspergillosis that hasn't responded to treatment
Exclusion Criteria:

• surgical or medical condition that makes participation difficult or potentially unsafe
• require care in an intensive care unit
Breathing, Lung & Sleep Health, Infectious Diseases
Clinics and Surgery Center (CSC), antifungal therapy, aspergillosis, fungal infection, lung infection, pulmonary aspergillosis
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Stability 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs Quad Tendon (Protocol # PRO19020231) (STABILITY 2)

The purpose of this multicenter study is to compare outcomes between patients who will undergo different types of ACL reconstruction. All patients will have a tendon from their own knee used to reconstruct the ACL. Prior to knee surgery, researchers will randomize (i.e. a coin toss) to determine if ACL reconstruction will be done with patellar or quadriceps tendon and if the lateral extra-articular tenodesis will or will not be added to the ACL surgery. We will follow-up with participants as they undergo treatment and recovery after surgery for 2 years.

Jeffrey Macalena
Not specified
This study is NOT accepting healthy volunteers
SITE00000971
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Inclusion Criteria:

• age 14-25
• ACL deficient knee
• at least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity
Exclusion Criteria:

• previous ACL repair on either knee
• partial ACL tear
• multiple ligament injury (two or more ligaments requiring surgery)
• pregnancy
Bone, Joint & Muscle
Clinics and Surgery Center (CSC), ACL, Anterior cruciate ligament reconstruction, joint instability
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A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

The main purpose of this study is to look at how safe and well tolerated the study drug is in combination with ribociclib (Group 1) or alpelisib (Group 2), the levels of the study drug and ribociclib or alpelisib in your blood, and how your body and your cancer respond.

David Potter
18 years and over
This study is NOT accepting healthy volunteers
SITE00001932
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Inclusion Criteria:

• at least 18 years old
• diagnosis of advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
• received no more than 2 prior hormonal regimens for advanced or metastatic disease
• received no more than 1 prior chemotherapy for locally advanced or metastatic breast cancer
Exclusion Criteria:

• significant heart disease
• cerebral vascular disease within 6 months
• pulmonary embolism, or deep venous thrombosis within the last 6 months
• pneumonitis or interstitial lung disease
• history or ongoing gastrointestinal disorders that result in poor absorption of medications
• history of significant liver disease
• study staff will review medical history
Cancer
Clinics and Surgery Center (CSC), alpelisib, HER2-neg breast cancer, HR-positive Breast Cancer, Metastatic Breast cancer, ribociclib
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MT2022-41 A Phase 1/2 Study Evaluating the Safety and Efficacy of a Single Dose of Autologous CD34+ Base Edited Hematopoietic Stem Cells (BEAM-101) in Patients with Sickle Cell Disease and Severe Vaso-Occlusive Crises (BEACON Trial) (BEACON)

BEAM-101 is an experimental new therapy being developed for treating people with SCD and vaso-occlusive crises. The goal of this study is to see if BEAM-101 is safe and effective for people in the study. The study sponsor and study doctors would also like to see if individuals who are treated with BEAM-101 require fewer blood transfusions and experience fewer vasoocclusive crises requiring hospitalization, compared to before they received BEAM-101. This study will also measure the levels of fetal hemoglobin along with measures that assess quality of life and ability to function following treatment with BEAM-101.

Ashish Gupta
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017341
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Inclusion Criteria:

• 18 to 35 years old
• documented diagnosis of sickle cell disease with specific genotypes (study staff will review)
• disease is severe
Exclusion Criteria:

• HbF levels >20%, obtained at the time of screening on or off hydroxyurea therapy
• previous transplant
• history of an overt stroke
Rare Diseases, Blood Disorders
Clinics and Surgery Center (CSC), SCD, Sickle Cell Disease
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MT2020-27: Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to Tisagenlecleucel (Kymriah) Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

This purpose of this study is to identify a safe dose level for the study drug, E7777, when given with standard tisagenlecleucel therapy (also known by its brand name, Kymriah, is an immunotherapy that is made from the participants own blood cells) in participants with Diffuse Large B-Cell Lymphoma (DLBCL). Up to three dose levels of E7777 will be tested.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00011895
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Inclusion Criteria:

• diagnosis of a relapse or refractory large B cell lymphoma, for which treatment with Kymriah is planned
• received two or more lines of systemic therapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of child bearing age must use birth control for 30 days following completion of treatment
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• women who are pregnant or breast feeding
• CNS involvement by malignancy
• eye disease or complaints visual acuity impairment, color or shape distortion, or blurred vision - potential participants are required to have an eye exam as part of screening
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Diffuse Large B Cell Lymphoma, DLBCL, High-grade B-cell Lymphoma
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An International, Phase 3, Randomized, Multicenter, Open label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT) (INSIGHT)

This study is being done to learn how well ripretinib works against cancer as compared to sunitinib in patients with a specific GIST-gene mutation who have received imatinib. We will also learn more about the safety of ripretinib and look at how ripretinib may affect your body. The choice of whether you will be given ripretinib or sunitinib will be assigned by a computer, by chance, like the flip of a coin. You will have a 2 out of 3 chances of receiving ripretinib. You will know if you are receiving ripretinib or sunitinib.

Keith Skubitz, MD
18 years and over
This study is NOT accepting healthy volunteers
SITE00001953
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Inclusion Criteria:

• diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample
• disease progression on imatinib treatment, confirmed by scan
• ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of reproductive potential must agree to follow contraception requirements
• contact study staff for additional inclusion criteria
Exclusion Criteria:

• known active central nervous system metastases
• heart disease, myocardial infarction within 6 months of starting the study, active ischemia or any other uncontrolled cardiac condition such as angina, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure
• Gastrointestinal abnormalities such as inability to take oral medication, malabsorption syndromes, requirement for intravenous alimentation
• additional exclusions apply malabsorption syndromes requirement for intravenous alimentation
Rare Diseases, Cancer
Clinics and Surgery Center (CSC), Advanced Gastrointestinal Stromal Tumor, GIST, Stomach Cancer
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See this study on ClinicalTrials.gov

MT2023-10: A Phase 1 Study of FT522 in Combination with Rituximab in Participants with Relapsed/Refractory B-Cell Lymphoma

We are studying FT522 - a new product that is made by modifying cells in a laboratory - both with and without additional drugs, to see if it can help treat people with B-cell lymphoma. This study is for people who have had at least one treatment for their lymphoma, but the cancer either returned or did not respond to the treatment. We are testing this product to see what side effects it might have, as well as to see whether it is effective at treating B-cell lymphoma.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
SITE00001976
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Inclusion Criteria:

• diagnosis of B-cell lymphoma (BCL)
• at least 1 prior systemic regimen of treatment
• men and women participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
Exclusion Criteria:

• women who are pregnant or breastfeeding
• capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
• body weight less than 50 kg (110 lb.)
• additional medical diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Lymphoma, Relapsed/Refractory B-Cell Lymphoma
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I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)

The I-SPY2 study uses 10 years of results to help your doctor understand more about your tumor and how to classify it better. This means your doctor will have more information and might be able to offer you a new treatment that could work better than the usual treatments. We need better treatments and better ways to identify which patients will benefit most from particular treatments.

Douglas Yee, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00011111
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Inclusion Criteria:

• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
Exclusion Criteria:

• other medical or mental health diagnosis that would limit compliance with study requirements
Cancer
Breast Cancer, Breast Tumors, I-SPY, ISPY, ISPY2

MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)

This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021552
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Inclusion Criteria:

• undergoing mismatched related (haploidentical) or unrelated allogeneic hematopoietic stem cell transplantation (HSCT)
• diagnosis of one of the following hematologic malignancies: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• weight is at least 35 kgs (77 pounds)
• available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation
• study staff will review additional inclusion and exclusion criteria
Exclusion Criteria:

• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
Cancer
blood cancer, hematopoietic stem cell transplantation (HSCT)
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MT2023-31: A multi-center, randomized, active controlled clinical trial to evaluate the efficacy and safety of OTL-203 in subjects with mucopolysaccharidosis type I, Hurler syndrome (MPS-IH) compared to standard of care with allogeneic hematopoietic stem cell transplantation (allo-HSCT) (HURCULES)

This research study is designed to compare a new gene therapy, known as OTL-203 (study drug), with a standard treatment called “allogeneic hematopoietic stem cell transplant” (allo-HSCT), to find out which is better for the treatment of MPS-IH.

Ashish Gupta
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00020015
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Inclusion Criteria:

• at least 28 days old to no more than 30 months old
• confirmed laboratory diagnosis of MPS-IH
• evidence of altered GAG metabolism
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• previous allo-HSCT or gene therapy
• diagnosis of HIV, Hepatitis B, Hepatitis C, or Mycoplasma
• history of uncontrolled seizures
• contraindications for MRI scans
• study staff will review additional exclusion criteria
Rare Diseases
Hurler syndrome, MPS-IH, mucopolysaccharidosis type I
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MT2023-22: Phase 1/2 Study of IDP-023 as a Single Agent and in Combination with Antibody Therapies in Patients with Advanced Hematologic Cancers

There are 2 phases to this clinical research study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 is to find the recommended dose of the study drug IDP-023 that can be given alone (referred to as a “monotherapy”), with or without interleukin-2 (IL-2) and in combination with another anti-cancer drug, either daratumumab in subjects with relapsed/refractory MM or rituximab in subjects with relapsed/refractory NHL. The goal of Phase 2 is to learn if the recommended dose of IDP-023 found in Phase 1 with or without IL-2 can help to control advanced MM or NHL when given in combination with daratumumab or rituximab, respectively.

Aimee Merino
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019972
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Inclusion Criteria:

• diagnosis of Multiple Myeloma (MM) that has relapsed or is refractory disease after 3 or more prior lines of therapy
• OR Non-Hodgkin Lymphoma (NHL) that has relapsed or is refractory after 2 or more lines of chemotherapy
• restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
Exclusion Criteria:

• significant cardiac disease
• Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection
• untreated central nervous system, epidural tumor metastasis, or brain metastasis
Cancer
Clinics and Surgery Center (CSC), MM, Multiple Myeloma, NHL, Refractory Multiple Myeloma, Refractory Non-Hodgkin Lymphoma
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Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus

The purpose of this research study is to learn more about how food affects blood sugar levels, and whether a continuous glucose monitor (CGM) can help to individualize nutrition education for people with diabetes. Participation in the study would require 3-4 clinic visits over a period of 14 weeks. Participants will also be asked to: meet with a registered dietitian every 2 weeks (virtually), keep food logs, wear a CGM and an activity monitor, answer survey questions, and provide blood samples to measure markers of diabetes control (like hemoglobin A1c).

Anne Bantle
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019848
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Inclusion Criteria:

• at least 18 years of age
• diagnosis of type 2 diabetes mellitus
• Hemoglobin A1c of 7.0 - 9.5%
• Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period
Exclusion Criteria:

• Type 1 diabetes mellitus
• treatment with insulin, sulfonylurea, or meglitinide
• use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
• BMI < 25 kg/m2
• weight change > 5 pounds in the 3 months prior to study enrollment
• estimated glomerular filtration rate <60 ml/minute/1.73 m2
• pregnant or breastfeeding
• anemia
• presence of any disease that would make adherence to the protocol difficult
Diabetes & Endocrine
Diabetes, T2D, Type 2 Diabetes
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Pathogen Genomics Center of Excellence: Prospective Surveillance of Respiratory Pathogens and Antimicrobial Resistance in Diverse Regional Populations (MINNE-LOVE-2)

Respiratory illnesses, including ear and sinus infections, colds, and pneumonias, are among the most common infectious diseases affecting Minnesotans across their lifespan. These diseases can be caused by many different types of microbes—bacteria, viruses and fungi—and different types of microbes may require different kinds of treatment. This research is being done to learn more about the specific types of microbes that cause respiratory infections in children and adults across the state of Minnesota over time. Antimicrobial resistance happens when microbes develop the ability to defeat the drugs designed to kill them. Through this study, we will learn which types of genes are carried by microbes living in the respiratory tract by collecting and analyzing nasal and oral specimen.

Beth Thielen
Not specified
This study is also accepting healthy volunteers
STUDY00019522
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Inclusion Criteria:

• age at least 18 years and able to provide informed consent AND willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness Or
• age less than 18 years within the same household of at least 1 adult participant in study AND parent/guardian available to provide informed consent AND self or parent/guardian willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness
Exclusion Criteria:

• presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., parent not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe)
• routine mucosal specimen collection is not medically advised (such as severe immunocompromising condition, bleeding disorder)
Community Health, Infectious Diseases, Respiratory System
germs, infection, respiratory illness, RSV, virus
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MT2023-16: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (also known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients with Unresectable Locally Advanced or Metastatic Cancer

This study will test TAK-186, an antibody that selectively targets EGRF-expressing tumor cells, to see if TAK-186 is safe in patients with unresectable, locally advanced or metastatic cancer.

Heather Beckwith
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019459
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Inclusion Criteria:

• unresectable, locally advanced or metastatic solid tumors are considered to express epidermal growth factor receptor (EGFR)
• willing to have new biopsy(s) for the study if it is possible
• able to care for self and do light work
• women of childbearing potential must be willing to use 2 forms of contraception throughout the study, starting at screening through 90 days after the last dose of TAK-186
• Males with partners of childbearing potential must use barrier contraception during the entire study treatment period through 120 days after the last dose of study drug and must not donate sperm during this period. Must also have partner use 2 forms of contraception (see above requirement)
• contact study staff for additional study requirements
Exclusion Criteria:

• history of known autoimmune disease with some exceptions
• major surgery or traumatic injury within 8 weeks before first dose of study drug
• unhealed wounds from surgery or injury
• serious underlying medical or psychiatric condition that would impair the ability of the participant to consent, receive or tolerate the planned treatment (study staff will review)
• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), Colorectal Cancer, Non-small Cell Lung Cancer (NSCLC), Squamous Cell Cancer of Head and Neck (SCCHN)
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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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See this study on ClinicalTrials.gov

HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027

Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00001341
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Inclusion Criteria:

• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
Exclusion Criteria:

• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Hodgkin Lymphoma
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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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COLLABS: Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial

The purpose of this research is to determine the impact of providing personalized legal and financial services on the financial and emotional health of people with advanced stage colorectal cancer. We have partnered with a local nonprofit company called Cancer Legal Care (CLC) to provide the legal and financial services that people will receive as part of this research.

Arjun Gupta
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021793
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Inclusion Criteria:

• diagnosis of advanced stage colorectal cancer
• receiving care at the Masonic Cancer Center
• able to understand, speak, read, and write in English
Exclusion Criteria:

• lack capacity to consent
Cancer
Colon cancer, legal care
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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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See this study on ClinicalTrials.gov

Research Evaluating Vagal Excitation and Anatomical Links

We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.

John Osborn Jr.
18 years and over
This study is NOT accepting healthy volunteers
SITE00002000
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Inclusion Criteria:

• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
Exclusion Criteria:

• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
Brain & Nervous System, Mental Health & Addiction
Clinics and Surgery Center (CSC), Depression, Epilepsy, Vagal Nerve Stimulator, VNS
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ARACOG: A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated with Darolutamide or Enzalutamide (ARACOG)

To compare the effects of treatment with enzalutamide (ENZ) versus darolutamide (DARO) on the cognitive function of men with non-metastatic and metastatic castration-resistant prostate cancer (mCRPC) by comparing the change in the maximally changed cognitive domain from baseline in patients in each study arm by 24 weeks.

Stuart Bloom
18 years and over
This study is NOT accepting healthy volunteers
SITE00000986
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Inclusion Criteria:

• confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
• castration-resistant prostate cancer defined as 3 PSA rises at least 1 week apart, with the last PSA >2 ng/mL, while on treatment
• testosterone level of <50 ng/dL
• able to walk and care for self, but unable to work
• able to read & speak English
• able to swallow study tablets whole
Exclusion Criteria:

• prior chemotherapy for treatment of CRPC. Men who received chemotherapy for castrate-sensitive prostate cancer are eligible provided chemotherapy was completed more than 6 months ago
• prior treatment with specific drugs (study staff will review)
• radiation treatment for more than 21 days during enrollment in the study
• neurological diseases that affect thinking (dementia, seizures, etc.)
• chronic use of opiates that affects thinking
• significant history of falls or risk of falls
Cancer
Clinics and Surgery Center (CSC), Castration Resistant Prostate Cancer, CRPC, Metastatic Prostate Cancer, Prostate Cancer, Prostate Cancer
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MT2019-09: A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCR alpha beta +/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC) PIDTC CSIDE Protocol (CSIDE)

To determine the incidence of humoral immune reconstitution by 2 years post-transplant in 2 SCID cohorts (IL2RG/JAK3, RAG1/RAG2) undergoing alternative donor HCT by randomized assignment to a busulfan preparative regimen targeted at cumulative area-under-the-curve (cAUC) exposure of 25-35 mg*h/L vs 55-65 mg*h/ L.

Christen Ebens
0 years to 2 years old
SITE00000541
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Inclusion Criteria:

• Infants with SCID, either typical or leaky or Omenn syndrome. Typical SCID is defined as either of the following Absence or very low number of T cells (CD3+ T cells <300/microliter AND no or very low T cell function (<10% of lower limit of normal) as measured by response to phytohemagglutinin OR Presence of maternally derived T cells Leaky SCID is defined as the following • Absence of maternally derived T cells • AND either one or both of the following (i, ii): i) <50% of lower limit of normal T cell function as measured by response to PHA OR <30% of lower limit of normal T cell function as measured by response to CD3 ii) Absent or <10% of lower limit of normal proliferative responses to candida and tetanus toxoid antigens (must document post vaccination or exposure for this criterion to apply) • AND at least two of the following (i through iii): i) CD3 T cells < 1500/microliter ii) >80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (at < 4 years of age) AND/OR are oligoclonal T iii) Low TRECs and/or the percentage of CD4+/45RA+/CD31+ or CD4+/45RA+/CD62L+ cells is below the lower level of normal. Omenn syndrome • Generalized skin rash Maternal lymphocytes tested for and not detected. >80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (<2 years of age) Absent or low (up to 30% lower limit of normal (LLN)) T cell proliferation to antigens (Candida, tetanus) to which the patient has been exposed IF: Proliferation to antigen was not performed, but at least 4 of the following 8 supportive criteria, at least one of which must be among those marked with an asterisk (*) below are present, the patient is eligible as Omenn Syndrome. Hepatomegaly Splenomegaly Lymphadenopathy Elevated IgE Elevated absolute eosinophil count *Oligoclonal T cells measured by CDR3 length or flow cytometry (upload report) *Proliferation to PHA is reduced to < 50% of lower limit of normal (LLN) or SI < 30 *Low TRECs and/or percentage of CD4+/RA+ CD31+ or CD4+/RA+ CD62L+ cells below the lower level of normal
• Documented mutation in one of the following SCID-related genes a. Cytokine receptor defects (IL2RG, JAK3) b. T cell receptor rearrangement defects (RAG1, RAG2) 3. No available genotypically matched related donor (sibling) 4. Availability of a suitable donor and graft source Haploidentical related mobilized peripheral blood cells 9/10 or 10/10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells 5. Age 0 to 2 years at enrollment Note: to ensure appropriate hepatic metabolism, age at time of busulfan start: For IL2RG/JAK3: 8 weeks For RAG1/RAG2: 12 weeks
• Adequate organ function defined as: Cardiac: Left ventricular ejection fraction (LVEF) at rest ≥ 40% or, shortening fraction (SF) ≥ 26% by echocardiogram. Hepatic: Total bilirubin < 3.0 x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilbert's Disease are allowed to exceed this limit) and AST and ALT < 5.0 x ULN for age. Renal: GFR estimated by the updated Schwartz formula ≥ 90 mL/min/1.73 m2. If the estimated GFR is < 90 mL/min/1.73 m2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 50 mL/min/1.73 m2. Pulmonary No need for supplemental oxygen and O2 saturation > 92% on room air at sea level (with lower levels allowed at higher elevations per established center standard of care).
Exclusion Criteria:
Presence of any serious life-threatening or opportunistic infection at time of enrollment and prior to the initiation of the preparative regimen. Serious infections as defined below that occur after enrollment must be reported immediately to the Study Coordinating Center, and enrollment will be put on hold until the infection resolves. Ideally enrolled subjects will not have had any infection. If patients have experienced infections, these must have resolved by the following definitions: a. Bacterial i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site must be negative and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). ii. Tissue-based clinical infection (e.g. cellulitis): Complete resolution of clinical signs (e.g. erythema, tenderness, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). iii. Pneumonia, organism not identified by bronchoalveolar lavage: Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). If possible, radiographic resolution should also be demonstrated. b. Fungal i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site is negative and patient has completed appropriate course of antifungal therapy (typically at least 14 days). The patient may be continued on antifungal prophylaxis following completion of the treatment course. c. Pneumocystis i. Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of therapy (typically at least 21 days). If possible, radiographic resolution should also be demonstrated. The patient may be continued on prophylaxis following completion of the treatment course. d. Viral i. Viral PCRs from previously documented sites (blood, nasopharynx, CSF) must be re-tested and are negative. ii. If re-sampling a site is not clinically feasible (i.e. BAL fluid): Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.). If possible, radiographic resolution should also be demonstrated. Patients with HIV or HTLV I/II infection will be excluded.
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A Phase IB/II Multi-Cohort Study of Targeted Agents with Atezolizumab for Patients with Recurrent or Persistent Endometrial Cancer (EndoMAP)

The purpose of this study is to learn the effects, good or bad, of several possible study treatments for EndoCA that are selected based on genetic markers that can be found in these tumors.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001240
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Inclusion Criteria:

• recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy
Exclusion Criteria:

• primary invasive ovarian or cervical cancer occurring with this cancer
• other cancer occurring in the past 5 years
• active or history of autoimmune disease or immune deficiency
• history of cardiac, respiratory or neurological conditions (study staff will review)
Cancer, Women's Health
Clinics and Surgery Center (CSC), EndoCA, Endometrial Cancer
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MT2021-24: A Phase I Open Label Study to Evaluate the Safety and Tolerability of ISP-001 in Adult Patients with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie

The purpose of the study is to determine the safety and effectiveness of a new procedure to treat Mucopolysaccharidosis Type I Hurler-Scheie and Scheie (MPS I). This procedure involves collecting some white blood cells (termed “B cells”) and growing them outside of the body in a laboratory. While the cells are in the lab, the B cells will be changed to produce more of the IDUA that is missing. This process is called “genetic modification.” The newly modified B cells are then infused back into the participant.

Paul Orchard
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016974
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Inclusion Criteria:

• diagnosis of Mucopolysaccharidosis type I Hurler-Scheie or Scheie syndrome
• creatinine clearance, calculated or measured directly, that is greater than 60ml/min/1.73m2
• ejection fraction at least 40% by echocardiogram
• must agree to stay <45-minute drive from the study site for a minimum of 5 days after cell infusion.
• must commit to traveling to the study site for the necessary follow-up evaluations.
Exclusion Criteria:

• known family inherited cancer syndrome
• had a previous hematopoietic stem cell transplant (HSCT)
• any medical condition likely to interfere with assessment of safety or efficacy of the study treatment (study staff will review)
Rare Diseases
Mucopolysaccharidosis IH/S, Mucopolysaccharidosis IS
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MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies

The research aspect of this trial is the use of a new machine to remove specific lymphocytes from the donor’s peripheral blood stem cells (PBSCs). This is called T cell receptor alpha/beta T cell depletion. This machine does such a good job at removing the unwanted donor T cells, and as a result we think patients will need fewer drugs to suppress their immune system.

Margaret MacMillan, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00016450
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Inclusion Criteria:

• hematological cancer needing stem cell transplant
• 60 years old or younger
Exclusion Criteria:

• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
Cancer
Hematologic Malignancy, Leukemia, Stem Cell Transplant, Clinics and Surgery Center (CSC)
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FAST, RELIABLE, ELECTRICAL UNCONSCIOUS DETECTION

We are interested in learning more about how preconscious thinking works. Preconscious thinking are thoughts you aren't actively thinking about but can be thought of quickly with the right trigger. It is similar to a waiting room for your thoughts. We believe that preconscious thoughts are important for learning more about symptoms related to suicide and psychosis. This research will help us better understand how the preconscious relates to these mental health outcomes. Participants will be asked to complete a research visit where they will complete computer tasks while being monitored with EEG and video recording. We'll also ask participants to complete pre-visit mood check-ins which can be done remotely.

Alik Widge
18 years and over
This study is also accepting healthy volunteers
SITE00001823
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Inclusion Criteria:

• age 18 to 65
• Must be UMN student
• reads/understands English
• have a smartphone compatible with EMA app or willing to use study loaner phone for duration of EMA collection period (optional for initial group)
• ability to travel to research site for in-person visit at M Health Fairview University of Minnesota Medical Center - West Bank
Exclusion Criteria:

• active military member or DoD personnel
• pregnant or possibility of being pregnant
• diagnosed with a mental illness (e.g. depression, bipolar, schizophrenia, etc.)
Mental Health & Addiction
Biomarkers, EEG, Mental Illness, Neuroscience, Psychology, Psychosis, Suicide
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An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose PR001A in Infants with Type 2 Gaucher Disease

PR001A is designed to deliver a normal GBA1 gene copy into the body to increase the activity of GCase, which is low in Type 2 Gaucher Disease (GD2) patients. The new GBA1 gene will remain a child’s body cells for many years and possibly for the rest of their life. A participant will need one surgery during which the study drug will be given and will stay in the hospital for at least 48 hours following the surgery.

Chester Whitley, MD, PhD
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00008823
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Inclusion Criteria:

• 0 to 24 months of age
• clinical diagnosis on Gaucher disease, Type 2 (GD2)
• Bi-allelic GBA1 mutation
• child has a reliable caregiver (i.e., parent/legal guardian) who is willing and able to participate in the study as a source of information on the patient's health status and cognitive and functional abilities
Exclusion Criteria:

• diagnosis of a significant CNS disease other than GD2
• able to walk independently
• any other significant medical diagnosis (study staff will review)
• significant laboratory test result abnormalities
• unable to tolerate diagnostic imaging (MRI, CT scan) or unable to tolerate contrast agent
• unable to have sedation or anesthesia
Rare Diseases
Gaucher disease, Type 2 (GD2)
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A Phase 1B and randomized phase 2 trial of megestrol acetate with or without ipatasertib in recurrent or metastatic endometrioid endometrial cancer

The study is divided into two portions. In the first phase, we want to test the safety of a drug called ipatasertib, by testing different doses of the drug to see which dose is safer for people when given in combination with a fixed dose of a drug called megestrol acetate (MA). In Phase II, we are studying how safe the treatment is and how well it works. We are doing this study because we want to find out if this approach is better or worse than the usual approach for endometrial cancer.

Deanna Teoh
18 years and over
This study is NOT accepting healthy volunteers
SITE00001947
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Inclusion Criteria:

• grade 1 or 2 endometrioid endometrial cancer that has returned or has spread to other parts of the body (metastatic)
• may have received unlimited prior lines of treatment
• able to walk, care for self, and active at least 50% of the day
• able to swallow oral medications
• contact study staff for additional requirements
Exclusion Criteria:

• prior treatment with an AKT inhibitor
• women who are pregnant or breast feeding
• other medical or mental health diseases (study staff will review)
Cancer, Women's Health
Endometrial Cancer, Metastatic Endometrial Cancer, Clinics and Surgery Center (CSC)
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HM2023-11 PH I study of ven/aza or ven in combination with ziftomenib (KO-539) or 7+3 induction chemo with ziftomenib for AML pts

There are certain genetic changes in the leukemia cell thought to drive the disease in patients with acute myeloid leukemia. Ziftomenib is an investigational drug that blocks the menin pathway in hopes of preventing or slowing the leukemia cells from growing and dividing. The purpose of this study is to determine the safe dose of an investigational new drug (ziftomenib) used in combination with other study drugs i.e., venetoclax and azacitidine, to treat cancer. This will include an evaluation of side effects associated with ziftomenib in combination with the other study drugs and how ziftomenib works in combination with the other study drugs (venetoclax and azacitidine).

Mark Juckett
18 years and over
This study is also accepting healthy volunteers
SITE00001987
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Inclusion Criteria:

• newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) with specific mutation (study staff will review)
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• adequate liver, renal, and cardiac function
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:

• other types of leukemia
• active involvement of central nervous system
• clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
• women who are pregnant or breast feeding
• additional criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Acute Leukemia, Acute Myeloid Leukemia, AML, Leukemia
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