Active — Not RecruitingPhase 1

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

United States15 participantsStarted 2023-10-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines tazemetostat with CAR T cell therapy — can you explain what adding tazemetostat is trying to do differently compared to CAR T cell therapy alone, and why that combination might matter for my specific type of lymphoma?
2Since this is a Phase 1 trial and the main thing being measured is how many people experience side effects, does that mean we still don't know much yet about whether this combination actually helps shrink or control the lymphoma, and how should that uncertainty factor into my decision?
3The trial is listed as 'active but not recruiting' — does that mean there's no chance of me enrolling, and if so, are there similar trials still open that my care team could look into for me?
4CAR T cell therapy on its own already carries significant risks like cytokine release syndrome — would adding tazemetostat potentially make those side effects more frequent or more severe based on what's known so far?
5Given that I have a type of B-cell lymphoma that's included in this trial, would you recommend I consider standard or approved treatments first before looking at an early-phase combination study like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants who experience adverse events classified per CTCAEv5

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

Trial details

NCT IDNCT05934838

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-30

View on ClinicalTrials.gov More Follicular Lymphoma trials