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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05934838
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tazemetostat Pill — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 4, 2023
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tazemetostat and CAR T-Cell Therapy
    Tazemetostat is being administered prior to, and following, standard of care CAR T cell therapy. The use of tazemetostat in this way is investigational.

Primary Outcome Measure

Number of participants who experience adverse events classified per CTCAEv5 [ Time Frame: From start of treatment until 30 days after the last dose of tazemetostat, for a maximum of approximately 13 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine/NewYork-Presbyterian HospitalNew YorkNew York10065
Nicole Santos
[email protected]
646-962-6827
Samuel Yamshon, MD
[email protected]
Samuel Yamshon, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine/NewYork-Presbyterian Hospital· New York, NY

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