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NCT Number: NCT07175493

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

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

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Key information

Conditions

Autoimmune Cytopenia Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Autoimmune Hemolytic Anemia Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Evans Syndrome Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Immune Thrombocytopenia (ITP) Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Henan Cancer Hospital, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM336 Injection

Biological

subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol

Primary outcomes

  1. Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 52 weeks

    Safety will be assessed by monitoring the incidence, nature, and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs) such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), graded according to NCI CTCAE v5.0 and American Society for Transplantation and Cellular Therapy(ASTCT) criteria. Dose interruptions, modifications, or discontinuations due to toxicity will also be recorded.

  2. Efficacy of CM336

    Time frame: 8 weeks

    Overall hematological response rate within 8 weeks

  3. Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit.

    Time frame: up to 52 weeks.

    Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit.

  4. Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.

    Time frame: up to 52 weeks.

    Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

86+028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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