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.