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

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

Recruiting
18 years and older
All
Phase 1/2

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Overview

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

Eligibility

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.

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

NCT07175493

Keymed Biosciences Co.Ltd

1 February 2026

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