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

Keymed Biosciences

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Immune Thrombocytopenia (ITP)

Evans Syndrome

Autoimmune Cytopenia

Autoimmune Hemolytic Anemia

Treatments

Biological: CM336 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT07175493

CM336-125101

Details and patient eligibility

About

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

Enrollment

158 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.