他泽司他联合 CAR-T 细胞疗法治疗 B 细胞淋巴瘤的可行性研究

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

主要终点：Number of participants who experience adverse events classified per CTCAEv5 · Adverse reactions will be graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. · From start of treatment until 30 days after the last dose of tazemetostat, for a maximum of approximately 13 months
次要终点：Number of patients who experience cytokine release syndrome (CRS) by ASTCT Consensus Grading system during therapy；Number of patients who experience immune effector cell neurotoxicity syndrome (ICANS) by ASTCT Consensus Grading system during therapy；Overall response rate (ORR) reported as per Lugano response criteria；Mean Progression-Free Survival (PFS)；Mean Overall Survival (OS)

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

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.