Status:
RECRUITING
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Autoimmune Cytopenia
Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 18 2028
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT07175493
Start Date
November 18 2025
End Date
November 18 2028
Last Update
December 17 2025
Active Locations (3)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China
2
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
3
Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China