Study of BCMA-CD3 Bispecific Antibody CM336 for Treating Adult Primary Immune Thrombocytopenia

What this Trial Is About

Immune thrombocytopenia ITP is an autoimmune disease that causes low platelet counts and bleeding in the skin and mucous areas. Researchers are evaluating the safety and effectiveness of CM336, a BCMA-CD3 bispecific antibody, for treating adults with refractory primary ITP who have not responded well to standard treatments. This Phase 2 study addresses the urgent need for better therapies for patients with persistent or chronic ITP who have exhausted other options. Participants will receive subcutaneous CM336 using a step-up dosing schedule according to the study protocol. The study plans to enroll 20 to 30 adults who will be monitored over 52 weeks. The treatment aims to reduce harmful antibody-producing cells by targeting BCMA-positive B cells and plasma cells, potentially resetting the immune response responsible for ITP. During the study, participants will undergo regular assessments including platelet count measurements, bleeding evaluations, and antibody testing. Safety will be closely monitored for one year, while efficacy will be assessed at 12 weeks and throughout the study. The research team will track how well CM336 controls platelet levels and reduces the need for emergency treatments, aiming to improve quality of life for those with refractory ITP.

An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia