A Phase II Study of TT-01488 Tablets in Combination With Anti-CD20 Monoclonal Antibody Therapy in Patients With Mantle Cell Lymphoma

The study comprises three combination treatment cohorts: Cohort A, TT-01488 plus rituximab; Cohort B, TT-01488 plus rituximab plus an immunomodulatory agent; and Cohort C, TT-01488 plus rituximab plus a BCL2 inhibitor. Each treatment cohort consists of two parts: dose exploration (Part A) and efficacy exploration (Part B). Cohort A will be initiated first. The Safety Monitoring Committee (SMC) will conduct a comprehensive review and assessment based on the safety data from Cohort A, incorporating all available pharmacokinetic (PK) and preliminary efficacy data. Based on the SMC's recommendations, the study team will determine the timing for sequential initiation of Cohorts B and C. Part A of Cohort A uses a randomized, open-label design. Twelve patients with relapsed or refractory MCL will initially be enrolled and randomized 1:1 to two different TT-01488 tablet dose groups, receiving TT-01488 tablets plus rituximab 375 mg/m². Part B uses a Simon two-stage design, enrolling treatment-naïve MCL patients to receive TT-01488 at the recommended phase 2 dose (RP2D) plus rituximab 375 mg/m².