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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)

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT06500273

Population:

Adult

Phase:

II

The study aims to see if CAR T cells made from healthy donors are an effective study treatment to prevent relapse in participants who have lymphoma DNA detected in their blood by an investigational test. The study evaluates two investigational products – ALLO- 647, an antibody (protein) that may help prepare the body for receiving CAR T cells from healthy donors, and a CAR T cell study treatment called cemacabtagene ansegedleucel or cema-cel. Both ALLO-647 and cema-cel are investigational drugs and therefore not approved by the Food and Drug Administration (FDA). For reference, CAR T...
A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT06534983

Population:

Adult

Phase:

II

This study is testing a drug called autogene cevumeran in combination with nivolumab, a cancer treatment drug known for treating bladder cancer. The purpose of this study is to compare the effects, good or bad, of autogene cevumeran plus nivolumab versus nivolumab on patients with Muscle Invasive Urothelial Carcinoma (MIUC.) In this study, you will get either autogene cevumeran plus nivolumab or saline plus nivolumab. Autogene Cevumeran is not approved by the Food and Drug Administration to treat muscle-invasive urothelial cancer. Are you Eligible? (Inclusion Criteria) 18 years or older - For...
A Phase 2 Master Protocol to assess the efficacy and safety of FORE8394, an inhibitor of BRAF Class 1 and Class 2 alterations, in participants with cancer harboring BRAF alterations

Principal Investigator:

Mary R. Welch, MD, MS

Contact Number:

212-342-5162

NCT Number:

NCT05503797

Population:

Adult

Phase:

II

The purpose of this study is to test the safety of Plixorafenib and how well your disease responds to the study treatment. Plixorafenib has not been approved by the Food and Drug Administration (FDA). Your study treatment may or may not include a drug called Cobicistat. Cobicistat is approved by FDA but is not FDA approved in combination with plixorafenib. Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Ability to swallow and retain medication - Must not have known sensitivity to Plixorafenib and Cobicistat
A Phase 2 Study of Glofitamab and Obinutuzumab for first-line treatment of follicular lymphoma and marginal zone lymphoma

Principal Investigator:

Hua-Jay J Cherng, MD

Contact Number:

212-342-5162

NCT Number:

NCT05783596

Population:

Adult

Phase:

II

The purpose of this study is to determine how effective and safe the combination of glofitamab and obinutuzumab is in treating patients with Follicular Lymphoma (FL) and Marginal Zone Lymphoma(MZL) who have not received other treatments for their lymphoma. The investigators hope that combining these two drugs can provide a more effective study treatment regimen for these diseases. In addition, pre-study treatment with obinutuzumab may reduce side effects associated with glofitamab study treatment, like cytokine release syndrome. The U.S. Food and Drug Administration (FDA) has not approved...
A phase 2 study of fixed therapy with pirtobrutinib and obinutuzumab in previously untreated chronic lymphocytic leukemia (POP)

Principal Investigator:

Andrew H Lipsky, MD

Contact Number:

212-342-5162

NCT Number:

NCT06333262

Population:

Adult

Phase:

II

The purpose of this study is to learn about possible initial treatments for chronic lymphocytic leukemia (CLL). This study will evaluate the investigational drug pirtobrutinib in combination with the commercially available drug obinutuzumab to treat CLL. The U.S. Food and Drug Administration (FDA) has approved pirtobrutinib for the treatment of CLL that has returned (relapsed) or is resistant to other treatments. Pirtobrutinib i is not FDA approved for the first-time treatment of CLL. The FDA has approved obinutuzumab for the Are you Eligible? (Inclusion Criteria) Must be ≥18 years of age...
AALL1721: A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy

Principal Investigator:

Prakash Satwani, MD

Contact Number:

212-342-5162

NCT Number:

NCT03876769

Population:

Pediatrics/Adult

Phase:

II

The purpose of this study is to find out if the study drug, tisagenlecleucel, is safe and has benefits for people who have high-risk B-cell Acute Lymphoblastic Leukemia (B-ALL) and have a tiny number of leukemia cells still present in their bone marrow (MRD positive) at the end of consolidation (EOC) therapy. Tisagenlecleucel is a product made up of the patient's own T cells that have been changed to be able to identify and kill leukemia cells. Patients will receive chemotherapy followed by tisagenlecleucel and then be monitored to see how well the treatment worked. Are you Eligible? (...
A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients with Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05329766

Population:

Adult

Phase:

II

The purpose of this study is to help Arcus Biosciences, Inc. (the Sponsor) understand whether study drugs domvanalimab (also called AB154) plus zimberelimab (also called AB122) are safe and effective when given together with and without standard of care chemotherapy (FOLFOX) to patients with the type of cancer you have. Domvanalimab and zimberelimab are considered as immunotherapy. This type of treatment works by blocking a protein (programmed death-ligand 1, or PD-L1) that can cause tumors to grow. By blocking this protein, the study drugs may cause your cancer to stop growing or shrink...
A PHASE II MULTICENTER OPEN -LABEL TRIAL OF TAGRAXOFUSP (TAG) IN COMBINATION WITH VENETOCLAX AND AZACITIDINE (VEN/AZA) IN ADULTS WITH PREVIOUSLY UNTREATED CD123+ ACUTE MYELOID LEUKEMIA (AML) WHO ARE INELIGIBLE FORINTENSIVE CHEMOTHERAPY

Principal Investigator:

Sunil Girish Iyer, MD

Contact Number:

212-342-5162

NCT Number:

NCT06456463

Population:

Adult

Phase:

II

The purpose of this study is to determine if tagraxofusp (Tag) in combination with venetoclax (Ven) and azacitidine (Aza) can safely treat cancer in patients who have not received study treatment for their acute myeloid leukemia (AML) before. The combination of Tag with Ven and Aza is experimental and this combination of all 3 drugs is not approved by the United States Food and Drug Administration (FDA) for the treatment for patients with AML. Are you Eligible? (Inclusion Criteria) Are you 18 years or older? -Are you able to give written informed consent and be able to comply with all study...
A Phase II Trial of Durvalumab with Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06050252

Population:

Adult

Phase:

II

This study is being done to answer the following question: How tolerable is the new combination of durvalumab with classic chemotherapy (gemcitabine and cisplatin) before surgery for your high-risk liver cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your liver cancer. The usual approach is defined as care most people get for liver cancer. Are you Eligible? (Inclusion Criteria) Age ≥ 18 years Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by...
A SINGLE ARM, MULTICENTER, PHASE II, OPEN-LABEL TRIAL TO EVALUATE EFFICACY OF ISATUXIMAB IN PATIENTS WITH MONOCLONAL GAMMOPATHY OF RENAL SIGNIFICANCE

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT04614558

Population:

Adult

Phase:

II

The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with Monoclonal Gammopathy of Renal Significance (MGRS). Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treatMonoclonal Gammopathy of Renal Significance (MGRS). This means that the use of isatuximab in this study is considered ‘investigational’. Are you Eligible? (Inclusion Criteria) • Are you 18 years of age or older? • Do you have persistent renal...

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