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A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

A Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia

NCT07175493•Keymed Biosciences Co.Ltd

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

Age

18 - No limit years

Sex

ALL

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.

Locations (3)

Henan Cancer Hospital

Zhengzhou, Henan, China

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Blood Disease Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

November 18, 2025

Primary Completion Date

November 18, 2027

Completion Date

November 18, 2028

Last Updated

December 17, 2025

Enrollment

158

ESTIMATED participants

Conditions

Autoimmune CytopeniaImmune Thrombocytopenia (ITP)Autoimmune Hemolytic AnemiaEvans Syndrome

Interventions

CM336 Injection

BIOLOGICAL

Contacts

Qian Jia

CONTACT

86+028-88610620 qianjia@keymedbio.com

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

National Longitudinal Cohort of Hematological Diseases

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

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