Phase 2Not yet recruiting
A Phase II Study of TT-01488 Tablets in Combination With Anti-CD20 Monoclonal Antibody Therapy in Patients With Mantle Cell Lymphoma
A Multicenter, Open-Label, Phase II Dose-Exploration and Expansion Study to Evaluate TT-01488 Tablets in Combination With an Anti-CD20 Monoclonal Antibody-Containing Regimen for the Treatment of Mantle Cell Lymphoma.
- Sponsor
- TransThera Sciences (Nanjing), Inc. (Industry)
- Enrollment
- 188 planned
- Conditions
- Mantle Cell Lymphoma (MCL)
- Interventions
- TT-01488 Tablets; Rituximab; Immunomodulatory Agent; BCL2 Inhibitor
- Ages
- adults, older adults
- Registry
- NCT07855016
Full record on ClinicalTrials.gov
From the registry
This is a multicenter, open-label, phase II study evaluating TT-01488 in combination with different anti-CD20 monoclonal antibody-containing regimens for the treatment of treatment-naïve mantle cell lymphoma (MCL).
Primary outcomes
- Part A Dose-limiting toxicity (DLT)
- Part B Complete Response Rate (CRR) After 6 Cycles of Induction Therapy
History
Primary completion expected
Started
Registered