CM336 treatment for relapsed or refractory autoimmune cytopenia

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

This trial will test whether CM336, a BCMA/CD3 bispecific antibody given by injection, can help adults with relapsed or refractory autoimmune cytopenias such as ITP, AIHA, or Evans syndrome.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Keymed Biosciences Co.Ltd (industry)
• Locations: 3 sites (Zhengzhou, Henan and 2 other locations)
• Trial ID: NCT07175493 on ClinicalTrials.gov

What this trial studies

This is a Phase 1/2, open-label, multicenter interventional trial in China testing CM336 (a BCMA/CD3 bispecific antibody) administered by injection to adults with relapsed or refractory autoimmune cytopenias. Phase 1 focuses on safety, tolerability and dose finding, while Phase 2 explores clinical activity against cytopenias. Eligible conditions include immune thrombocytopenia, warm and cold autoimmune hemolytic anemia, mixed AIHA, and Evans syndrome, with key exclusions for secondary causes of cytopenia and major comorbidities. The trial is sponsored by Keymed Biosciences and conducted at three hospital sites in Henan, Shanxi, and Tianjin.

Who should consider this trial

Good fit: Adults aged 18 or older with relapsed or refractory ITP, warm/cold/mixed AIHA, or Evans syndrome, ECOG 0–2, who can give informed consent and comply with study visits are the intended participants.

Not a fit: Patients with secondary autoimmune cytopenias due to another defined disorder, other non-specified cytopenias, or those with serious uncontrolled comorbidities are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, CM336 could provide a new targeted option to reduce blood cell destruction and decrease dependence on steroids, transfusions, or other immunosuppressive therapies in refractory autoimmune cytopenias.

How similar studies have performed: BCMA-targeted therapies have shown clinical activity in B-cell/plasma-cell malignancies, but applying BCMA/CD3 bispecifics to autoimmune cytopenias is a novel and only minimally studied approach to date.

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.

Where this trial is running

Zhengzhou, Henan and 2 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• Heping Hospital Affiliated to Changzhi Medical College — Changzhi, Shanxi, China (RECRUITING)
• Blood Disease Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Qian Jia

Conditions: Autoimmune Cytopenia, Immune Thrombocytopenia, Autoimmune Hemolytic Anemia, Evans Syndrome