RecruitingPhase 1NCT05934838

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

Sponsor

Weill Medical College of Cornell University

Enrollment

15 participants

Start Date

Oct 4, 2023

Study Type

INTERVENTIONAL

Conditions

Follicular Lymphoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a drug called tazemetostat (which affects how genes are turned on and off in cancer cells) with CAR T-cell therapy (a personalized immune cell treatment) is safe and feasible for people with B-cell lymphomas such as DLBCL, follicular lymphoma, or mantle cell lymphoma. **You may be eligible if...** - You have been diagnosed with DLBCL, follicular lymphoma (FL), or mantle cell lymphoma (MCL) - You are eligible to receive standard CAR T-cell therapy - You have had at least 1 prior treatment for your lymphoma **You may NOT be eligible if...** - You have active HIV, hepatitis B, or hepatitis C infection - You have an active, uncontrolled systemic infection - You are being treated for another active cancer - You are pregnant or breastfeeding - You are unable to take oral medications - You have had a recent stroke, pulmonary embolism, heart attack, uncontrolled heart failure, severe high blood pressure, or certain heart rhythm problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTazemetostat Pill

Participants will take 800 mg of tazemetostat twice a day starting 7 days before apheresis and continue to take tazemetostat until lymphodepletion, which is chemotherapy given prior to receiving the CAR T cells. Participants will stop taking tazemetostat after lymphodepletion until after CAR T cell infusion. Once lymphocyte counts increase, tazemetostat will be resumed and tazemetostat will be taken for 6 - 12 months, depending on participant response.