RecruitingPhase 1Phase 2NCT07175493

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

Sponsor

Keymed Biosciences Co.Ltd

Enrollment

158 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Autoimmune Hemolytic Anemia Evans Syndrome Autoimmune Cytopenia Immune Thrombocytopenia (ITP)

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria5

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.

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