Search Results
A Phase 1/2 First-in-Human, Open-Label, Dose Escalation and Expansion Trial of TAK-505 Monotherapy in Participants with Unresectable Locally Advanced or Metastatic Solid Tumors
The purpose of this study is to evaluate how TAK-505 works in people with certain advanced solid tumors, including stomach, colorectal, lung, and head and neck cancers. The study will test TAK-505 at different dose levels to understand how it is tolerated, how it behaves in the body, and to help determine the dose that provides the best balance of effect and side effects for future studies.
• confirmed locally advanced or metastatic solid tumor (including stomach, colorectal, lung, and head and neck cancers) that has progressed after standard treatment or has no standard treatment options remaining
• adequate bone marrow, kidney, and liver function
• see link to clinicaltrials.gov for complete inclusion criteria
• significant uncontrolled medical conditions, including serious heart disease, lung disease, active infection, or recent major surgery active autoimmune disease requiring treatment or known HIV, hepatitis B, or hepatitis C infection
• active or unstable brain metastases or other untreated central nervous system disease
• see link to clinicaltrials.gov for complete exclusion criteria
MT2025-24: A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
This study is for people who have been diagnosed with advanced cancer that has not has not responded to standard treatment. FT836 is a type of cell product made up of “T cells” which are part of the immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells. We want to test the safety of FT836 at different doses, to understand how the body processes and responds to FT836, and to find out what effects FT836 may have on participants and the cancer. The study will also find out what effects FT836, when given alone and with or without chemotherapy treatment (paclitaxel) and/or a monoclonal antibody (cetuximab or trastuzumab.
• confirmed locally advanced or metastatic cancer including breast cancer, ovarian cancer, endometrial carcinoma, gastric/GEJ cancer, head & neck cancer, non small cell lung cancer, or colorectal cancer
• women & men of childbearing age must use highly effective birth control
• may not be able to do physically strenuous activity but walking and able to 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
• women who are pregnant or breastfeeding
• other cancer in the past two years
• significant cardiac (cardiac arrhythmias, myocardial infarction, unstable angina or congestive heart failure) or neurological disease (stroke, epilepsy, CNS vasculitis, or neurodegenerative disease)
• active central nervous system (CNS) involvement
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 1/2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors (FOG-001-101)
This study is for people who have been diagnosed with cancer that is advanced (means disease has spread from the original site or has come back) or is metastatic (means the disease has spread to other parts of the body). FOG-001 is currently being developed to treat people with cancer. We want see how safe and tolerable FOG-001 is when given alone and together with other anticancer drugs at different dose levels in participants. We also want to see how FOG-001 affects the body and the cancer
• locally advanced or metastatic solid tumor
• may not be able to do physically strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for specific requirements by type of tumor
• history of bone metastasis except patients with mCRPC
• Osteoporosis
• uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)
• women who are pregnant, breastfeeding, or planning to be come pregnant
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2025-31: A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)
The purpose of this study is to test a new CAR T-cell therapy called AZD0120 in adults with multiple myeloma that has returned or has not responded to previous treatments. Researchers want to learn whether this therapy is safe, determine the best dose to use, and see how well it works against the cancer. The study will also look at how the treatment affects the immune system and participants’ quality of life.
• diagnosed with multiple myeloma
• have multiple myeloma that has come back or has not responded to treatment
• have received at least 3 prior lines of treatment, including commonly used multiple myeloma therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• had serious side effects from prior CAR T-cell or similar immune-based therapies
• have another active cancer, significant medical condition (such as heart, neurological, mental health, autoimmune, or serious infection-related conditions), or plasma cell leukemia (some exceptions may apply)
• have had a recent stroke, seizure, bleeding in the brain, dementia, or major changes in mental status
• have multiple myeloma affecting the brain or central nervous system
• see link to clinicaltrials.gov for complete exclusion criteria
MT2026-02: A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis (SWOG S2213)
The purpose of this study is to compare two treatment approaches for people with amyloidosis: daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) chemotherapy followed by an autologous stem cell transplant versus Dara-VCD followed by daratumumab maintenance therapy without a stem cell transplant.
• diagnosis of systemic amyloid light chain (AL) amyloidosis
• may receive up to one cycle (or 28 days) of therapy prior to starting the study
• may be receiving chronic corticosteroids if they are being given for other disorders
• must be willing to undergo high dose chemotherapy and autologous stem cell transplantation
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding
• other uncontrolled illnesses including diabetes, hypertension, heart or lung disease
• see link to clinicaltrials.gov for complete exclusion criteria
PREvention of Cardiovascular and DiabEtic kidNey disease in Type 2 Diabetes (PRECIDENTD) (PRECIDENTD)
People with type 2 diabetes have a higher risk for heart disease than people without diabetes. We are doing this research to learn more about which diabetes medications are the best for lowering the risk of heart and kidney disease for people with type 2 diabetes. People who are in the study will be randomly (by chance) assigned to take one of two types of diabetes medications that have been approved by the FDA. Your usual care provider will continue to manage your diabetes care.
• 40 to 80 years old with -diagnosis of Type 2 diabetes, HbA1c ≥6% measured in the past 12 months,
• AND one of the following:
• diagnosis of coronary heart disease, cerebrovascular disease, or symptomatic peripheral artery disease
• OR: -60-80 years old and at least 1 additional high-risk feature:
• active smoking, HbA1c ≥ 8% measured within past 12 months or chronic kidney disease
• willing to be randomly (by chance) assigned to a class of medication and fill the prescription with personal pharmacy insurance plan
• see link to clinicaltrials.gov for complete inclusion criteria
• any other type of diabetes
• history of diabetic ketoacidosis
• active diabetic foot ulcer
• history of pancreatitis
• active treatment for cancer
• history of solid organ or bone marrow transplant
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 3, multicenter, clinical study to evaluate the efficacy and safety of safusidenib erbumine in participants with isocitrate dehydrogenase 1 (IDH1)-mutant glioma (SIGMA) (SIGMA)
This study is evaluating safusidenib, an investigational oral medication, for people with certain types of IDH1-mutant glioma. The study has three parts and will examine how well safusidenib works, how safe it is, and how the body processes the medication. Depending on the type and stage of glioma, participants may receive safusidenib after standard treatment, safusidenib or placebo, or safusidenib following surgery.
• 18 years of age or older
• have a confirmed IDH1-mutant glioma that has returned, progressed, or meets the study-specific criteria for treatment
• have received the required prior treatment for their type of glioma, which may include surgery, radiation therapy, chemotherapy, or other standard treatments
• have measurable tumor remaining or recurring that can be seen on imaging
• see link to ClinicalTrials.gov for complete Inclusion criteria
• prior treatment with certain medications targeting IDH1/IDH2 or other investigational treatments for glioma
• tumor involves the brainstem or spinal cord, or there is evidence of cancer spread along the lining of the brain or spinal cord
• significant medical, neurological, or heart conditions that could interfere with participation in the study
• see link to ClinicalTrials.gov for complete Exclusion criteria
MT2025-20: A Phase II, multi-part, five-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis
The goal of this study is to find out if the experimental drug rapcabtagene autoleucel (herein referred to as YTB323), an investigational new therapy, is safe and effective (can help) for people who have severe refractory diffuse cutaneous systemic sclerosis (dcSSc). YTB323 is a chimeric antigen receptor T cell (CAR-T cell) therapy, which is a type of gene therapy or immunotherapy. CAR-T involves collecting and using a patient’s own immune cells, specifically their T cells, to treat their condition.
• 18 to 70 years old
• diagnosis of systemic sclerosis and meet the criteria for diffuse cutaneous (dcSSc)
• Disease onset from the first symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within past 7 years
• severe, progressive systemic sclerosis disease
• see link to clinicaltrials.gov for complete Inclusion criteria
• Rheumatic disease other than dcSSc
• pulmonary hypertension
• significant kidney disease
• uncontrolled hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria
HM2026-09: Phase 3 Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma who Have Received 1-3 Prior Lines of Therapy (Trilogy5) (TRIlogy-4)
The purpose of this study is to evaluate a new study drug, JNJ-79635322, in adults with multiple myeloma that has returned after treatment or has not responded to previous treatment. Participants must have received 1 to 3 prior lines of therapy, including lenalidomide and an anti-CD38 antibody. Researchers want to learn how safe the study drug is and how well it works compared with the current standard treatment for multiple myeloma.
• diagnosed with multiple myeloma
• have multiple myeloma that has come back or has not responded to treatment
• have received at least 3 prior lines of treatment, including a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-CD38 antibody
• see the ClinicalTrials.gov listing for complete inclusion criteria
• have an active hepatitis infection
• have multiple myeloma that has spread to the brain or central nervous system
• have certain allergies to the study medications or their ingredients
• have had major surgery within the past 2 weeks, are still recovering from surgery, or have surgery planned during the study
• have received or plan to receive a live vaccine within 4 weeks before starting the study or during study treatment
• see the ClinicalTrials.gov listing for complete exclusion criteria
MT2023-01:Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (AdaptNK) for High-Risk Myeloid Diseases as Bridge to Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to evaluate the safety of a new NK cell therapy for people with relapsed or treatment-resistant acute myeloid leukemia (AML). Participants will receive chemotherapy followed by an infusion of specially selected donor immune cells designed to help the body recognize and fight leukemia cells. Researchers will study the safety of this treatment, determine the most appropriate dose, and learn more about how the therapy works in the body.
• diagnosis of acute myeloid leukemia (AML)
• adequate heart, lung, liver, and kidney function
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breast feeding
• diagnosed with leukemia involving the brain or spinal fluid
• active HIV, Hepatitis B, Hepatitis C, other serious infection, recent heart attack, or another active cancer requiring recent chemotherapy
• see link to clinicaltrials.gov for complete exclusion criteria
National Liver Cancer Screening Trial (TRACER)
Finding liver cancer early is important to increase chances of getting treatment and decreasing risk of dying from cancer. The purpose of this research is to compare the effectiveness of two liver cancer screening methods to detect liver cancer at an early stage. Participants will be randomly (by chance) placed in one of two study groups – one group will undergo ultrasound imaging of the liver with or without a blood test to measure a specific protein, whereas the second group will undergo a blood test for liver cancer screening called a GALAD score. The GALAD score combines three blood tests to screen for liver cancer. We do not currently know if GALAD would help detect liver cancer earlier than standard screening.
• 18 to 85 years old
• diagnosis of cirrhosis of the liver of any cause, or Hepatitis B
• physician has determined patient is eligible for for hepatocellular carcinoma (HCC) screening
• history of liver cancer or clinical symptoms of liver cancer
• presence of another active cancer besides skin cancer
• history of organ transplant
• active listing for liver transplant
• history of alcohol related liver inflammation within 3 months
• known pregnancy at the time of consent
• active warfarin use
Registry Study of Childhood Cancer in Minnesota
The aim of this study is to obtain newborn blood spots (NBS) and tumor specimens for children and adolescents diagnosed with malignant neoplasms.
• 0 to 21 years of age
• child diagnosed with any type of tumor or cancer
• born in a state that banks newborn blood spots
• able to understand English or Spanish
• parents or siblings may also contribute specimens
MT2024-25: Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
This study’s strategy is to take a personalized approach, using a type of donor source combined with a drug regimen specific to that source. The common risks of a transplant approach include graft failure – when the transplant does not take; graft versus host disease (GVHD) – when the transplanted donor cells attack the recipient; and a late effect of infertility. We are studying whether this new approach with conditioning regimen matched with donor source is safer and more effective than our previous approach. Additionally, we are testing whether the dose of radiation will reduce the risk of graft failure.
• 0 to 55 years old
• diagnosis of sickle cell disease (SCD) with transfusion dependent alpha- or beta- thalassemia, diamond blackfan anemia, or other non-malignant hematologic disorders
• sexually active people of childbearing potential or people with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after transplant
• study staff will review additional requirements
• women who are pregnant, breast feeding, or who plan to become pregnant during the study period
• HIV positive
• active uncontrolled infection
A Phase 1B/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), A B7- H3 Antibody-Drug Conjugate (ADC), In combination with Atezolizumab with or Without Carboplatin as First Line Induction or Maintenance, In Subjects with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)
This study is being done to learn more about the safety and effectiveness of ifinatamab deruxtecan (I-DXd) against extensive stage small cell lung cancer.
• diagnosis of extensive small cell lung cancer
• have not received any prior treatment (first line therapy)
• may be unable to do physically strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• agree to use a contraceptive method that is highly effective
• see link to clincialtrials.gov for complete inclusion criteria
• any of the following within the past 6 months: cerebrovascular accident, (CVA) transient ischemic attack, (TIA) or another arterial thromboembolic event
• uncontrolled or significant cardiovascular disease
• history of another cancer in the past 5 years
• history of bone marrow, stem cell, or solid organ transplant
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY (RESTORATiVE303)
The purpose of RESTORATiVE303 is to see if the study drug, which is called VE303, is safe and effective in preventing another episode of Clostridioides Difficile Infection (CDI). VE303 is an investigational drug that has 8 strains of live bacteria, called “commensals.” Commensals are the type of bacteria that live in harmony with the body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make one sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.
• at least 12 years old
• laboratory-confirmed Clostridium Difficile Infection (CDI) and at least one prior occurrence of CDI within the last 6 months
• OR 75 years or older with laboratory confirmed CDI
• OR CDI with additional risk factors
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
• history of chronic diarrhea unrelated to CDI
• history of celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months) of intestinal ischemia or ischemic colitis
DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer (DE-01)
The purpose of this research is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy (Carboplatin and Paclitaxel).
• diagnosis of epithelial endometrial cancer
• HER2 positive
• advanced disease (Stage III/IV) or first recurrent endometrial cancer
• first time systemic anticancer therapy or may have received one prior line of chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred ≥ 6 months after last dose of chemotherapy
• may not be able to do strenuous activity but walking and able to 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
• history of organ transplant
• other ongoing or active illness such as infection, serious chronic gastrointestinal conditions associated with diarrhea, active non-infectious skin disease requiring systemic treatment, heart or lung diseases
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer (KLK2-comPAS)
The purpose of this study is to understand if a new immune treatment (pasritamig) added to best supportive care (including radiation, steroids, pain medication, or medications to strengthen your bones) for metastatic castration-resistant prostate cancer will work better than the best supportive care alone for patients without other treatment options.
• diagnosis of metastatic castration-resistant prostate cancer (mCRPC): Disease is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs
• PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
• at least able to walk and so all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• exhausted all approved therapies or no additional treatments recommended or tolerable
• see link to clinicaltrials.gov for complete Inclusion criteria
• blood clot in the last month
• active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications or more than 10 mg of prednisone daily
• significant lung disease (2 liters of oxygen or more)
• another cancer
• heart disease in the past six months (heart attack, stroke, or heart failure)
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors
This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.
• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
AALL2131; An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia
This phase III trial compares the effect of the combination of blinatumomab with dasatinib and standard chemotherapy versus dasatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (PH+) or Philadelphia chromosome-like (Ph-Like) ABL-class B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib in combination with standard chemotherapy may work better in treating patients with PH+ or Ph-Like ABL-class B-ALL compared to dasatinib and chemotherapy alone.
• Age: Patients must be >365 days and < 22 at the time of enrollment
• Diagnosis: Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
• Known history of chronic myeloid leukemia (CML)
• ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
• Down syndrome (trisomy 21)
• Pregnancy and breast feeding
MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy
This study will test GTB-5550, a B7H3-targeted natural killer (NK) cell engager, for the treatment of select solid tumor cancers. The study will determine the optimal dose level and evaluate preliminary safety and efficacy.
• confirmed cancer that can be measured on scans
• fully active, able to care for yourself
• have recovered from side effects of any prior cancer treatments
• have adequate blood counts, kidney, liver, heart, and lung function based on recent lab tests
• see link to clinical trials.gov for complete Inclusion criteria
• recent cancer treatment (within 2 weeks)
• have had a prior organ transplant
• are pregnant or breastfeeding
• another active or recent cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
This study is testing a stem cell (bone marrow) transplant for people with certain blood disorders. The goal is to find a treatment approach that is effective while causing fewer side effects. Participants will receive treatment to prepare their body, followed by a transplant using stem cells from a donor. After the transplant, they will receive medications to help prevent complications.
• up to 75 years of age
• have a matched related donor
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• recent stem cell transplant within the past 3 months
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
This study is testing an investigational drug called XmAb541 for people with advanced solid tumors that test positive for a protein called CLDN6. XmAb541 is a type of immunotherapy designed to help the body's immune system recognize and attack cancer cells. The first part of the study will test different doses of XmAb541 to determine a safe and appropriate dose for future research. Once a recommended dose is identified, additional participants will receive that dose in the second part of the study. Researchers will evaluate the safety of XmAb541, how the body responds to the treatment, and whether it shows signs of helping to control or shrink cancer.
• ovarian, fallopian tube, peritoneal, endometrial, uterine, or another CLDN6-positive cancer that has returned, spread, or not responded to previous treatment
• able to carry out most daily activities with limited assistance
• see link to ClinicalTrials.gov for complete Inclusion Criteria
• active autoimmune disease
• significant heart, lung, or gastrointestinal disease
• active hepatitis B or hepatitis C infection
• see link to ClinicalTrials.gov for complete Exclusion Criteria
MT2024-12: A Phase 1 Study Evaluating BAFFR-targeting CAR T cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
The purpose of this study is to assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B- cell non-Hodgkin lymphoma (B-NHL). We also will determine the maximum tolerated dose (MTD)/RP2D of BAFFR-CART cells.
• able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Large B-cell lymphoma (LBCL) or Mantle Cell Lymphoma (MCL)
• cancer has recurred or not responded to at least 2 prior lines of treatment
• willing to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of medication
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• prior allogeneic stem cell transplant
• Autologous stem cell transplant within 6 months
• Auto-immune disease or condition requiring systemic immunosuppressant therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
• significant cardiac disease including heart failure or arrhythmia
• history of a stroke in the past 6 months
• history of another active cancer in the past 3 years
• women who are pregnant or breast feeding
MT2023-51 A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer
This study is being done to learn more about the efficacy and safety of LN-145 in participants with metastatic stage IV non-small cell lung cancer.
• confirmed diagnosis of metastatic Stage IV NSCLC without specific genomic alterations
• if the tumor has a treatable mutation(s) (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate targeted therapy is required
• may be restricted from strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent
• have any form of primary immunodeficiency
• had another primary cancer within the previous 3 years
HM2025-23: Phase 3 Randomized, Double-Blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 mutated or KMT2A Rearranged Acute Myeloid Leukemia
AML is a type of blood cancer where infection fighting cells called white blood cells (WBCs) don’t grow up or “mature” like they are supposed to. Instead, they stay stuck as infant or immature “blast” cells. This study will investigate the potential risks and benefits of adding a targeted therapy called ziftomenib to intensive therapy (7+3) OR non-intensive (Venetoclax + Azacitidine) for patients whose cancers are found to have KMT2A rearrangements or mutations in the NPM1 gene. We will also see if the use of ziftomenib as maintenance therapy following consolidation is beneficial.
• diagnosis of Acute Myeloid Leukemia (AML)
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• must agree to use a highly effective method of birth control
• see link to clincialtrials.gov for complete Inclusion criteria
• received prior therapy for AML
• involvement of central nervous system
• history of another type of cancer
• women who are pregnant or breastfeeding
• other significant medical illness,
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2025-06: Postmarketing, Prospective, Observational, Study to Assess and Characterize the Risk of Secondary Malignancies, and Long-term Safety Following Treatment with atidarsagene autotemcel (Lenmeldy )
To assess and characterize the risk of malignancies, and long-term safety following treatment with atidarsagene autotemcel (Lenmeldy).
• live in the United States
• has been or will be treated for MLD with Lenmeldy
Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus
This study is looking at whether rezpegaldesleukin can help preserve insulin-producing cells in people who were recently diagnosed with type 1 diabetes. Participants will receive treatment every 2 weeks for 26 weeks, followed by a 6-month follow-up period.
• age 8 to 45 years
• recently diagnosed with type 1 diabetes (T1D) within the past 100 days
• have at least one blood test showing an immune response associated with T1D and some remaining insulin production
• see link to ClinicalTrials.gov for complete Inclusion criteria
• current or recent serious infection, including tuberculosis, HIV, or hepatitis B or C
• currently taking medications that suppress the immune system or have recently received certain immune-modulating treatments
• history of certain serious heart conditions, cancer, or organ transplant
• currently pregnant or breastfeeding, or planning to become pregnant during the study
• see link to ClinicalTrials.gov for complete Exclusion criteria
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 azer-cel), 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.
• 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)
• 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
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.
• 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
• 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)
A first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, EIK1003 (IMP1734), as monotherapy and in combination in participants with advanced solid tumors
This study tests IMP1734, a PARP1-selective inhibitor, in patients with breast, ovarian, or metastatic castration-resistant prostate cancer (mCRPC) with specific HRR gene mutations. The study includes dose escalation to identify the maximum tolerated or achievable dose (MTD/MAD), dose optimization to evaluate the safety, tolerability, and effectiveness of select doses, and dose expansion to test the recommended dose for monotherapy. IMP1734 is taken as daily oral tablets, and the trial lasts up to three years from the first treatment of the last participant.
• breast cancer: must have had at least one prior chemotherapy in the neoadjuvant, adjuvant, or metastatic setting and hormonal therapy if HR+
• HGSOC, high-grade endometrioid EOC, fallopian tube, or primary peritoneal cancer: must have had at least one prior platinum-based chemotherapy for advanced disease
• mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy
• must agree to use an effective method of contraception from study entry up to 6 months after the last dose of IMP1734
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• recent anti-cancer therapy (within 28 days) or prior use of PARP1-selective inhibitors
• active CNS metastases, carcinomatous meningitis, or significant cardiac issues (QTcF >470 ms or <340 ms)
• active infections, including hepatitis B or C, or bleeding disorders
• inability to swallow oral medications or conditions affecting drug absorption