Phase 12 Study of CM336 Injection for Adults With Relapsed or Refractory Autoimmune Cytopenia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CM336, a BCMACD3 bispecific antibody, in treating patients with relapsed or refractory autoimmune cytopenia. This includes conditions such as immune thrombocytopenia ITP, autoimmune hemolytic anemia AIHA, cold agglutinin disease, mixed AIHA, and Evans Syndrome. The study is a phase 12 clinical trial sponsored by Keymed Biosciences Co. Ltd, aiming to assess the treatments impact on these blood disorders. Participants will receive subcutaneous injections of CM336 following a step-up dosing schedule as outlined in the study protocol. The dosing frequency and amount of CM336 are carefully adjusted during the trial. This interventional study does not include placebo or masking, focusing solely on assessing CM336s effects. During the study, participants will be monitored for up to 52 weeks to evaluate the incidence and severity of adverse events, serious adverse events, and treatment efficacy. Key measurements include platelet counts for ITP subjects and hemoglobin levels for AIHA subjects, tracked at multiple visits. Participants must provide informed consent, meet specific health criteria, and will undergo regular safety and efficacy assessments throughout the trial duration.

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia