NCT07175493 A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
| NCT ID | NCT07175493 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Keymed Biosciences Co.Ltd |
| Condition | Autoimmune Cytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2027-11-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 158 participants in total. It began in 2025-11-18 with a primary completion date of 2027-11-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07175493 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autoimmune Cytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07175493 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07175493 currently recruiting?
Yes, NCT07175493 is actively recruiting participants. Contact the research team at qianjia@keymedbio.com for enrollment information.
Where is the NCT07175493 trial being conducted?
This trial is being conducted at Zhengzhou, China, Changzhi, China, Tianjin, China.
Who is sponsoring the NCT07175493 clinical trial?
NCT07175493 is sponsored by Keymed Biosciences Co.Ltd. The trial plans to enroll 158 participants.