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A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas


Description

This is a clinical trial to evaluate the feasibility and safety of giving tazemetostat followed by standard of care CAR T cell infusion in previously treated diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). The investigators hypothesis is that this combination has the potential to significantly improve the ability of CART cells to recognize and kill lymphoma cells without a significant impact on safety. Participants will receive the tazemetostat pills before and after receiving their CAR T cell therapy, for up to 12 months after CAR T cell administration. Patients will be followed for up to 5 years.This is a single arm, open label, clinical trial to evaluate the feasibility and safety of oral tazemetostat followed by standard of care CAR T cell infusion in previously treated DLBCL, FL, and MCL. The investigators hypothesis is that this combination has the potential to significantly improve the ability of CART cells to recognize and kill l

Trial Eligibility

Inclusion Criteria: * Confirmed diagnosis of DLBCL, FL, or MCL * Eligible to receive standard of care CAR T cells * Have received at least 1 prior therapies Exclusion Criteria: * Active viral infection with HIV or hepatitis type B or C * Active, uncontrolled systemic fungal, bacterial or viral infection * Active treatment for another cancer * Pregnant or breastfeeding * Unable to take oral medication * Certain significant past medical history, such recent stroke, pulmonary embolism, myocardial infarction, congestive heart failure, uncontrolled hypertension, or certain arrhythmias

Study Info

Organization

Weill Medical College of Cornell University


Primary Outcome

Number of participants who experience adverse events classified per CTCAEv5


Outcome Timeframe From start of treatment until 30 days after the last dose of tazemetostat, for a maximum of approximately 13 months

NCTID NCT05934838

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2023-10-04

Completion Date 2026-09

Enrollment Target 15

Interventions

DRUG Tazemetostat Pill

Locations Recruiting

Weill Cornell Medicine/NewYork-Presbyterian Hospital

United States, New York, New York


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