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Recruiting NCT07175493

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

Phase I / Phase II Interventional Autoimmune Cytopenia Immune Thrombocytopenia (ITP) Autoimmune Hemolytic Anemia Evans Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CM336 Injection.
Who it may be relevant to
Registry conditions: Autoimmune Cytopenia, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia, Evans Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: 52 weeks]
  • Efficacy of CM336 [Time frame: 8 weeks]
  • 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 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Henan Cancer Hospital — Zhengzhou
  • Heping Hospital Affiliated to Changzhi Medical College — Changzhi
  • Blood Disease Hospital, Chinese Academy of Medical Sciences — Tianjin

Identifiers

NCT: NCT07175493 · CM336-125101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗