A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia (NCT07175493) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
China158 participantsStarted 2025-11-18
Plain-language summary
To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 52 weeks
2
Efficacy of CM336
Timeframe: 8 weeks
3
Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit.
Timeframe: up to 52 weeks.
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.