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

A Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia

To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia

Inclusion Criteria:

• Voluntary provision of written informed consent and ability to comply with protocol requirements.
• Age ≥18 years, male or female.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
• Confirmed diagnosis of immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), mixed autoimmune hemolytic anemia (mAIHA) or Evans Syndrome.
• Relapsed or refractory autoimmune hemolytic anemia.

Exclusion Criteria:

• Secondary ITP or AIHA caused by any reason. Subjects with positive autoimmune antibodies but without a clear diagnosis of any other autoimmune diseases are allowed to be enrolled.
• Other types of AIHA or other types of cytopenia
• History of critical diseases that, in the opinion of the investigator, may pose a risk to the safety of subjects or whose exacerbation during the study could compromise the efficacy or safety analysis of the results.
• Received any treatment of anti-B Cell Maturation Antigen(BCMA) antibody.
• Evaluated unsuitable to participant in this study by investigator.