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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.

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MT2024-07:A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Systemic Lupus Erythematosus (RESET-SLE)

The purpose of this study is to find out what dose of CABA-201 can be safely administered to patients with SLE, including those with lupus nephritis (LN). SLE is thought to involve B cells that cause the body to attack different tissues in the body including your skin, joints, kidneys, heart, lungs, brain, and blood cells. LN is a type of kidney disease caused by SLE. CABA-201 is a chimeric antigen receptor T cell (CAR T) therapy. In this study, we will take some of your T cells, a type of white blood cell, and genetically modify them (put in a “code”) so that they may find and remove the B cells in your body, including the B cells that are involved in causing your disease. Once your cells are modified, CABA-201 cells will be re-infused into your body intravenously (through the vein).

Principal Investigator: Patrick Nachman
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019751
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 65 years old
• diagnosis of Systemic Lupus Erythematosus (SLE)
• positive antinuclear antibody (ANA) titer or anti-dsDNA antibody
Exclusion Criteria:

• active infection requiring medical intervention
• presence of kidney disease other than active lupus nephritis
• prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
• additional medical conditions (study staff will review)
Conditions: Immune Diseases
Keywords: Clinics and Surgery Center (CSC), Lupus, Lupus Nephritis, SLE, Systemic Lupus Erythematosus
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A Phase I/IIa, First-in-Human, Multicenter, Monotherapy and Combination-Therapy with Nivolumab, Dose-Finding and Dose-Expansion Study of (212Pb)VMT01 Melanocortin-1-Receptor-Targeted, Image-Guided, Alpha-Particle Therapy in Subjects with Previously Treated Unresectable or Metastatic Melanoma (VMT01-T101)

This study is testing a radioactive treatment for adults with advanced melanoma that has spread, cannot be removed by surgery, or has gotten worse after prior treatment. We want to learn how safe the treatment is and how well it may work. By taking part, participants may help us learn whether this could become a useful treatment option for people with advanced melanoma.

Principal Investigator: Benjamin Manning
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025911
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 18 or older
• diagnosed with advanced melanoma that cannot be removed by surgery, has spread, or has returned
• previously received at least one approved treatment for advanced melanoma and had the cancer worsen
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• have another active cancer
• are pregnant or breastfeeding
• have previously received systemic treatment with radioactive medicines
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer, Melanoma, Nivolumab
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MT2025-51: A RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEMACABTAGENE ANSEGEDLEUCEL IN PARTICIPANTS WITH MINIMAL RESIDUAL DISEASE AFTER RESPONSE TO FIRST LINE THERAPY FOR LARGE B-CELL LYMPHOMA (ALPHA3) (ALPHA3)

This study is for adults with large B-cell lymphoma whose cancer responded to standard treatment but still shows small amounts of disease on a specialized blood test. Participants will be randomly assigned to receive either an investigational CAR T-cell therapy or standard follow-up observation to compare safety and how well each approach helps prevent the lymphoma from returning.

Principal Investigator: Veronika Bachanova, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027450
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older
• diagnosed with certain types of large B-cell lymphoma (LBCL)
• completed standard first-line treatment without needing additional therapy
• cancer is in complete remission or partial remission suitable for observation after first-line treatment
Exclusion Criteria:

• lymphoma has spread to the brain or spinal cord, or developed from another type of cancer
• previously treated with anti-CD19 therapy
• active autoimmune disease or a serious infection requiring treatment
• another cancer or bone marrow disorder diagnosed within the past 3 years
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer, large B-cell lymphoma, LBCL
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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.

Principal Investigator: Ashish Gupta
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023330
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
Exclusion Criteria:

• women who are pregnant, breast feeding, or who plan to become pregnant during the study period
• HIV positive
• active uncontrolled infection
Conditions: Blood Disorders
Keywords: Clinics and Surgery Center (CSC), SCD, Sickle cell disease
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Biorepository to Support ALS Research in Minnesota

The purpose of the study is to establish and maintain a biorepository of tissue and biospecimen samples relevant to Amyotrophic Lateral Sclerosis (ALS) research. We will obtain, store, and catalogue peripheral blood mononuclear cells (PBMCs), blood and blood components, skin punch biopsy samples, and cerebral spinal fluid (CSF) from people living with ALS, linked to clinical datasets, to advance ALS research.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022317
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• People living with ALS: people with a confirmed diagnosis of ALS
• Controls: people who have a neurological disorder other than ALS for which a comparison will assist in medical discovery Healthy controls: Individuals without ALS or other neurological disorders.
Exclusion Criteria:

• age less than 18 or greater than 90
Conditions: Brain & Nervous System, Rare Diseases, Rare Diseases
Keywords: ALS, amyotrophic lateral sclerosis, Clinics and Surgery Center (CSC)
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A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients with Severe Alopecia Areata with an Open-Label Extension Period

The purpose of this study is to determine if deuruxolitinib is a safe and effective treatment for adolescents ages 12 to 17 with severe alopecia areata and at least 50% scalp hair loss.

Principal Investigator: Maria Hordinsky
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025881
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 12-17
• moderate to severe alopecia areata with at least 50% scalp hair loss
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• have a scalp condition, such as psoriasis or seborrheic dermatitis, that requires treatment
• taking medications or other treatments that could affect hair growth or your immune system
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Dermatology (Skin, Hair & Nails), Children's Health
Keywords: Alopecia Areata, AA, hair loss
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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.

Principal Investigator: Mark Juckett
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027586
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of acute myeloid leukemia (AML)
• adequate heart, lung, liver, and kidney function
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion 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
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), acute myeloid leukemia, AML
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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.

Principal Investigator: Anne Blaes, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011111
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Cancer
Keywords: Breast Cancer, Breast Tumors, I-SPY, ISPY, ISPY2, Clinics and Surgery Center (CSC)

RANDOMIZED PHASE III TRIAL OF NEOADJUVANT IMMUNOTHERAPY WITH RESPONSE-ADAPTED TREATMENT VERSUS STANDARD-OFCARE TREATMENT FOR RESECTABLE STAGE III/IV CUTANEOUS SQUAMOUS CELL CARCINOMA

We are studying the use of immunotherapy before and after (in some cases) surgery to see if it will extend the length of time until the cancer returns compared to the usual approach. The usual approach for patients who are not in a study is treatment with surgery which may be followed by radiation. Participants will either get the study drug cemiplimab (REGN2810) before surgery for the cancer or will have up-front surgery. For those who receive cemiplimab (REGN2810), it will be given before surgery every 3 weeks for up to 12 weeks. In either case, participants may also receive radiation after surgery depending on the tumor tissue results from surgery.

Principal Investigator: Curtis Hanba
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025188
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
• previously untreated or recurrent CSCC
• walking and able to do self-care, but unable to work; up and about at least 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• history of solid organ or bone marrow transplant
• no active, known, or suspected autoimmune disease for the past 5 years
• current significant medical issues
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Eyelid Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma, Clinics and Surgery Center (CSC)
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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.

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022432
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
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
Conditions: Cancer
Keywords: LBLC, Mantle Cell Lymphoma (MCL), Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
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A Randomized Phase II Study Comparing Sequential High dose Testosterone and Enzalutamide to Enzalutamide alone in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer

The goal of this current study is to test whether men with prostate cancer that is getting worse after treatment with hormone therapy and abiraterone respond better to alternating treatment with testosterone and enzalutamide vs. enzalutamide alone. We are testing to see which is better at stopping tumor growth that can be seen on a bone scan or CT scan and the effect of each regimen on lowering Prostate Specific Antigen (PSA values). Participants will be in the study for 6 to 24 months.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001730
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of adenocarcinoma of the prostate
• spread (metastatic) to other organs or bone
• one chemotherapy treatment for hormone sensitive prostate cancer is allowed
• previous treatment required, study staff will review
• able to care for self with little help
Exclusion Criteria:

• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Castration Resistant Metastatic Prostate Cancer (CRPC), Prostate cancer
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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

Principal Investigator: Ajay Prakash
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025544
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Conditions: Cancer
Keywords: cancer, metastatic cancer, Clinics and Surgery Center (CSC), solid tumor
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EXPANDED ACCESS PROGRAM TO TREAT PATIENTS WITH PREVIOUSLY TREATED METASTATIC PANCREATIC ADENOCARCINOMA WITH DARAXONRASIB

The purpose of this expanded access program is to provide the investigational medication daraxonrasib to adults with metastatic pancreatic cancer who have received previous treatment, have no satisfactory treatment options, and are unable to participate in a daraxonrasib clinical trial.

Principal Investigator: Alex Tsai
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00028794
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older able to take oral medication
• diagnosed with metastatic pancreatic cancer that has grown or spread after previous treatment
• received at least one prior treatment for metastatic pancreatic cancer
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• pancreatic cancer that has spread to the brain or central nervous system
• currently receiving another cancer treatment
• significant heart disease or an active, uncontrolled infection
• major surgery within the past 28 days
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center, CSC, Clinics and Surgery Center (CSC), pancreatic adenocarcinoma, pancreatic cancer, cancer

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.

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025913
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
Exclusion 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
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC)
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Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients with Locally Advanced or Metastatic Solid Tumors

This study is intended to find the highest amount of the study drug, VT3989, which can be safely taken by patients without causing too many side effects and to determine the recommended dose and dosing schedule for further research, how much of the study drug gets into the blood stream and how long it takes to be cleared, and if the study drug will shrink tumors.

Principal Investigator: Robert Kratzke
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019430
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit
• 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
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• active brain metastases or primary CNS (central nervous system) cancer
• HIV positive or active Hepatitis B or Hepatitis C
• significant heart disease
• another active cancer
• women who are pregnant or breastfeeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Mesothelioma, solid tumors
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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.

Principal Investigator: Jeremy Allred
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026093
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
Exclusion 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
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC)

The purpose of this research is to collect information about the safety and tolerability of the study drug ACE-232, along with how well it works to control metastatic castration-resistant prostate cancer (mCRPC).

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024643
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Metastatic Castration-resistant Prostate Cancer (MCRPC) with - ongoing androgen deprivation therapy (ADT) or had bilateral orchiectomy
• difficult to treat or intolerant to standard treatment
• may be 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
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• spinal cord compression or known brain metastases
• severe cardiovascular disorders
• known gastrointestinal (GI) disorder or GI procedure
• poorly controlled diabetes
• active or uncontrolled autoimmune disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), MCRPC, Metastatic Castration-resistant Prostate Cancer, Prostate Cancer
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PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)

This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.

Principal Investigator: David Potter
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001846
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
Exclusion Criteria:

• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
Conditions: Cancer, Women's Health
Keywords: Clinics and Surgery Center (CSC), Breast Cancer, Breast Cancer, HER2+ breast cancer, ISPY
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Longitudinal Study of Porphyrias

The objective is to conduct a longitudinal investigation of the natural history, complications, and therapeutic outcomes in people with acute and cutaneous porphyria.

Principal Investigator: Marshall Mazepa, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000892
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• patient of any age
• diagnosis of a porphyria
• biochemical findings, as documented by laboratory reports of porphyria-specific testing performed after 1980
Exclusion Criteria:

• elevations of porphyrins in urine, plasma or erythrocytes due to other diseases
Conditions: Rare Diseases
Keywords: Acute Porphyrias, Cutaneous Porphyrias
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EFC17574: A Phase 3, single-arm, multicenter, multinational, open label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged >= 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX (ATLAS-NEO)

A study to test a medicine (fitusiran) injected under the skin for preventing bleeding episodes in male adolescent or adult participants with severe Hemophilia.

Principal Investigator: Jacob Cogan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00017896
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Sex: Male
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 years or older
• diagnosis of severe congenital hemophilia A or B
• participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months
Exclusion Criteria:

• co-existing bleeding disorders other than congenital hemophilia A or B
• current participation in immune tolerance induction therapy (ITI)
• prior treatment with gene therapy
• acute hepatitis, ie, hepatitis A, hepatitis E, acute or chronic hepatitis B infection
• additional exclusion criteria apply (study staff will review)
Conditions: Blood Disorders
Keywords: Hemophilia
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MT2023-42: A Phase 1 Study of FT819 in B-Cell Mediated Autoimmune Diseases

This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.

Principal Investigator: Parastoo Fazeli
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020865
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
Exclusion Criteria:

• active neurological symptoms of SLE
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant
Conditions: Immune Diseases
Keywords: Clinics and Surgery Center (CSC), SLE, Systemic Lupus Erythematosus
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PIOGLITAZONE-METFORMIN COMBINATION TREATMENT FOR HIGH RISK ORAL PRENEOPLASIA

The purpose of this study is to learn about the safety and effects of pioglitazone and metformin on people and their risk of cancers of the head or neck. We hope to learn more about the potential for pioglitazone and metformin to be used as a way to prevent oral or oropharyngeal cancers in people who are at risk for those cancers. Participants will get both pioglitazone and metformin, as a single pill to be taken at the same time for 12 weeks.

Principal Investigator: Frank Ondrey
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001771
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• hyperplasia in high risk areas (floor of mouth, mobile tongue, oropharynx) confirmed by biopsy
• able to swallow a tablet whole
• Body mass index (BMI) is ≥ 18.5
• sexually active persons of child-bearing potential agrees to use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding or planning to become pregnant
• diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent
• history of bladder cancer, including in situ bladder cancer
• history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) in past 18 months
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Community Health
Keywords: Clinics and Surgery Center (CSC), Oral Leukoplakia
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REMIND: An Investigator Initiated Study Testing the Feasibility of Maintenance Radiotherapy for Patients with Newly Diagnosed Glioblastoma (REMIND)

This study is testing whether a single additional treatment of radiation therapy, called maintenance radiotherapy, is safe and feasible for adults who have recently been diagnosed with glioblastoma (GBM). Participants will first receive their usual treatment for GBM, including surgery, radiation therapy, and the chemotherapy drug temozolomide. About one month after completing standard radiation therapy, participants will receive one additional treatment of radiation therapy. The study will also look at changes in certain immune cells before and after the additional radiation treatment. Participants will continue their usual follow-up care every 2 to 4 months for up to 5 years after the additional treatment.

Principal Investigator: Lindsey Sloan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025989
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older
• newly diagnosed with glioblastoma (GBM) and planning to receive standard treatment, including surgery, radiation therapy, and temozolomide (TMZ)
Exclusion Criteria:

• currently pregnant or breastfeeding
• cancer involves the brainstem within the area planned for radiation
• previous radiation therapy to the brain
• unable to safely have MRI or CT scans
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Glioblastoma, Radiatiotherapy
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Studying Users' Interaction Behaviors with Social Media Algorithmic Curation

The purpose of this study is to learn how adults with depression or anxiety use TikTok in different situations and how their surroundings and emotions may affect their use. Participants will complete surveys, use an Android study app for 2 weeks, and share their TikTok data at the end of the study. What we learn may help guide the design of social media tools that better support mental well-being.

Principal Investigator: Stevie Chancellor
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00027670
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• age 18 or older and live in the United States
• use TikTok every day and use an Android phone
• self-identify as having depression or anxiety
Conditions: Mental Health & Addiction
Keywords: anxiety, depression, mental health, mental well-being, social media, TikTok
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Coordinated Reset Deep Brain Stimulation for Parkinson's Disease (CR DBS PD)

The purpose of this study is to learn whether a new way of delivering deep brain stimulation (DBS), called coordinated reset DBS, is safe and can improve symptoms in people with Parkinson’s disease. This approach uses different patterns and lower levels of stimulation than standard DBS. Participants will have or receive an implanted DBS system and receive coordinated reset stimulation during the study. What we learn may help improve future DBS treatments for people with Parkinson’s disease.

Principal Investigator: Jing Wang
Age Group: 21 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026868
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Sex: Male or Female
Age Group: 21 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 21 or older
• diagnosed with Parkinson’s disease
• have or will receive a Boston Scientific Vercise Genus Rechargeable DBS system
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• have another significant neurological condition or a muscle, bone, or joint condition that affects movement or walking
• have a significant psychiatric condition or cognitive impairment that would prevent participation
• are pregnant
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Brain & Nervous System, Rare Diseases
Keywords: Clinics and Surgery Center (CSC)
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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.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000151
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
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
Conditions: Cancer
Keywords: childhood cancer
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A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial EA2222

This study compares two treatment approaches for adults with colorectal cancer that has spread to the liver and cannot be removed by surgery. We want to learn whether adding a pump treatment helps control or shrink the cancer. By taking part in this study, participants may help us improve options for people with colorectal cancer that has spread to the liver.

Principal Investigator: Ajay Prakash
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027862
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 or older
• diagnosed with colorectal cancer that has spread to the liver, cannot be removed by surgery, and has not been found outside the liver
• received about 3-6 months of first-line chemotherapy and have cancer that is stable or responding to treatment
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• have previously received certain treatments directed at the liver, such as radiation or hepatic artery infusion therapy
• have cirrhosis or portal hypertension
• are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer, Colon Cancer, Colorectal Cancer, Liver Cancer
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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.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022784
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
Exclusion 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
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), small cell lung cancer
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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.

Principal Investigator: Elizabeth Aby
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023768
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Conditions: Cancer
Keywords: HCC, hepatocellular carcinoma, Liver Cancer, Clinics and Surgery Center (CSC)
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PEPN2312; A Phase 1 study of GRN163L (Imetelstat, IND# 170891, NSC# 754228) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia that is in second or greater relapse or that is refractory to relapse therapy; myelodysplastic syndrome or juvenile myelomonocytic leukemia in first or greater relapse or is refractory to relapse therapy

This phase I trial tests the safety, side effects, and best dose of imetelstat in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) that has not responded to previous treatment (refractory) or that has come back after a period of improvement (recurrent). Imetelstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imetelstat in combination with fludarabine and cytarabine may work better in treating patients with refractory or recurrent AML, MDS, and JMML.

Principal Investigator: Robin Williams
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022789
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Between 1 year and less than or equal to 18 years of age at enrollment
• Patients, with or without Down syndrome (DS), and with de novo acute myeloid leukemia, therapy-related AML, MDS or JMML.
• In second or greater relapse or refractory AML or First or greater relapse of MDS, or First or greater relapse of JMML
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• Pregnant or breast-feeding
• Currently receiving investigational drugs or other anti-cancer agents
Conditions: Cancer
Keywords: acute myeloid leukemia, AML, JMML, juvenile myelomonocytic leukemia, MDS, myelodysplastic syndrome
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