CM336 treatment for relapsed or refractory autoimmune cytopenia
Official title: A Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia
Run by Keymed Biosciences Co.Ltd · NCT07175493 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 158 (estimated) |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 3 sites (Zhengzhou, Henan and 2 other locations) |
| Status | Recruiting |
| Started | November 18, 2025 |
| Main results expected | November 18, 2027 |
| Study ends | November 18, 2028 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT07175493 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: qianjia@keymedbio.com
- Phone: 86+028-88610620
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.