TRANSTHERA-B(02617): The Phase II clinical trial of TT-01488 combined with anti-CD20 monoclonal antibody regimen for the treatment of peripheral T-cell lymphoma in China has been approved and will be launched.

TRANSTHERA-B (02617) announced that the company's product TT-01488 in combination with anti-CD20 monoclonal antibody regimen for the treatment of mantle cell lymphoma (MCL) has been approved by the National Medical Products Administration (NMPA) on July 1, 2026. This trial is a multicenter, open-label, dose exploration and expansion phase II study evaluating the combination of TT-01488 with anti-CD20 monoclonal antibody regimen for the treatment of mantle cell lymphoma. TT-01488 is a novel, non-covalent BTK inhibitor developed by the company. Kinase spectrum screening has shown excellent target activity, low affinity for EGFR and Tec, improved kinase selectivity, reduced off-target inhibition, decreased risk of atrial fibrillation, bleeding, and other toxic side effects, better safety potential, and demonstrated good anti-tumor activity in tumor lymphocyte heterotransplant models. Several clinical studies have confirmed that BTK inhibitors in combination with anti-CD20 monoclonal antibodies can enhance the efficacy of frontline treatment for mantle cell lymphoma. In a completed phase I clinical trial, among 10 evaluable non-germinal center type MCL patients, the objective response rate (ORR) was 70%, including 4 complete responses and 3 partial responses. Its unique mechanism of action combined with CD20 monoclonal antibodies can synergistically target killing and immune effects, potentially establishing an effective and low-toxicity frontline treatment option as an alternative to chemotherapy.