Actively Recruiting
A Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia
Led by Keymed Biosciences Co.Ltd · Updated on 2025-12-17
158
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CM336, a BCMA/CD3 bispecific antibody, in treating patients with relapsed or refractory autoimmune cytopenia. This includes conditions such as immune thrombocytopenia (ITP), autoimmune hemolytic anemia (AIHA), cold agglutinin disease, mixed AIHA, and Evans Syndrome. The study is a phase 1/2 clinical trial sponsored by Keymed Biosciences Co. Ltd, aiming to assess the treatment's impact on these blood disorders. Participants will receive subcutaneous injections of CM336 following a step-up dosing schedule as outlined in the study protocol. The dosing frequency and amount of CM336 are carefully adjusted during the trial. This interventional study does not include placebo or masking, focusing solely on assessing CM336's effects. During the study, participants will be monitored for up to 52 weeks to evaluate the incidence and severity of adverse events, serious adverse events, and treatment efficacy. Key measurements include platelet counts for ITP subjects and hemoglobin levels for AIHA subjects, tracked at multiple visits. Participants must provide informed consent, meet specific health criteria, and will undergo regular safety and efficacy assessments throughout the trial duration.
CONDITIONS
Brief Title
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary provision of written informed consent and ability to comply with protocol requirements.
- Age 18 years or older, 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.
You will not qualify if you...
- 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.
- Other types of AIHA or other types of cytopenia.
- History of critical diseases that may pose a risk to safety or compromise study results.
- Prior treatment with anti-B Cell Maturation Antigen (BCMA) antibody.
- Evaluated as unsuitable to participate by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive subcutaneous CM336 injections with step-up dosing according to the protocol to treat relapsed or refractory autoimmune cytopenia.
Visit schedule according to dosing protocol
Trial Site Locations
Total: 3 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
2
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Actively Recruiting
3
Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
Q
Qian Jia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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