The China National Medical Products Administration (NMPA) has granted approval for a Phase II clinical trial of TRANSTHERA-B's (ASX: 02617) product, TT-01488 tablets, in combination with an anti-CD20 monoclonal antibody regimen for the treatment of mantle cell lymphoma (MCL).

This trial is designed as a multicenter, open-label, dose-exploration and expansion Phase II study to evaluate the efficacy and safety of the TT-01488 combination therapy.

TT-01488 is a novel, non-covalent BTK inhibitor developed in-house by the company. Kinase profiling has demonstrated its excellent target activity, with low affinity for EGFR and Tec, leading to superior kinase selectivity. This profile is expected to minimize off-target inhibition, potentially reducing adverse effects such as atrial fibrillation and bleeding, thereby enhancing its safety profile. The compound has also shown promising anti-tumor activity in tumor lymphocyte xenograft models.

Multiple clinical studies have established that combining BTK inhibitors with anti-CD20 monoclonal antibodies can improve treatment outcomes for first-line MCL therapy.

In a completed Phase I clinical trial involving TT-01488, among 10 efficacy-evaluable patients with non-blastoid MCL, the objective response rate (ORR) was 70%. This included four cases of complete response and three cases of partial response.

The unique mechanism of action of TT-01488, when paired with a CD20 monoclonal antibody, is anticipated to synergistically target and kill cancer cells through combined direct and immune-mediated effects. This combination holds promise for developing a highly effective, low-toxicity, "chemotherapy-free" first-line treatment regimen.