Actively Recruiting
A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas
Led by Weill Medical College of Cornell University · Updated on 2025-08-15
15
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
E
Epizyme, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of combining tazemetostat, an oral medication, with standard CAR T cell therapy in patients with previously treated diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. The study aims to see if this combination can help CAR T cells better identify and kill lymphoma cells without causing significant safety issues. This is a phase 1, single-arm, open-label trial exploring this new approach. Participants will take 800 mg of tazemetostat pills twice daily starting at least one week before apheresis (a procedure to collect immune cells), continuing until lymphodepleting chemotherapy begins. They will pause tazemetostat during chemotherapy and CAR T cell infusion, then resume once blood counts recover. Depending on the response, tazemetostat treatment may continue for up to 6 months in those with complete responses or up to 12 months in those with partial responses. This treatment plan is investigational and designed to assess feasibility. During the study, participants will be monitored for side effects and treatment responses. Safety will be assessed by recording adverse events from the start of treatment until about 13 months afterward, including specific monitoring for cytokine release syndrome and neurotoxicity up to 21 days post-CAR T infusion. Researchers will also evaluate overall response rates, progression-free survival, and overall survival for up to 6 years. Participants will be followed for up to 5 years in total to understand long-term outcomes.
CONDITIONS
Brief Title
A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of diffuse large B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma
- Eligible to receive standard of care CAR T cell therapy
- Have received at least one prior therapy
You will not qualify if you...
- Active viral infection with HIV or hepatitis B or C
- Active, uncontrolled systemic fungal, bacterial, or viral infection
- Active treatment for another cancer
- Pregnant or breastfeeding
- Unable to take oral medication
- Significant past medical history including recent stroke, pulmonary embolism, myocardial infarction, congestive heart failure, uncontrolled hypertension, or certain arrhythmias
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 1 week
Participants take oral tazemetostat twice daily starting 7 days before apheresis to prepare for CAR T cell therapy.
1 visit for apheresis
Duration - Up to 12 months depending on response
Participants receive lymphodepletion chemotherapy followed by CAR T cell infusion. Tazemetostat is paused during lymphodepletion and resumed after CAR T cell therapy once blood counts recover, continuing for 6 to 12 months depending on response.
Multiple visits including lymphodepletion, CAR T infusion, and follow-up visits during treatment
Duration - Up to 6 years
Participants are monitored for safety and treatment efficacy, including adverse events, cytokine release syndrome, neurotoxicity, and disease progression for up to 6 years.
Regular visits scheduled for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
Research Team
N
Nicole Santos
S
Samuel Yamshon, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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