About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CM336 Injection

Treatment groups

158 Participants
are divided into 1 treatment group

Locations

3
Henan Cancer Hospital ZhengzhouHenan, China
Heping Hospital Affiliated to Changzhi Medical College ChangzhiShanxi, China
Blood Disease Hospital, Chinese Academy of Medical Sciences TianjinTianjin Municipality, China

Sponsors and collaborators

Keymed Biosciences Co.Ltd

Lead sponsor