Actively Recruiting
An Open, Exploratory Clinical Study to Assess Safety and Efficacy of BCMA-CD3 Bispecific Antibody CM336 in the Treatment of Primary Immune Thrombocytopenia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-03-13
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Immune thrombocytopenia (ITP) is an autoimmune disease that causes low platelet counts and bleeding in the skin and mucous areas. Researchers are evaluating the safety and effectiveness of CM336, a BCMA-CD3 bispecific antibody, for treating adults with refractory primary ITP who have not responded well to standard treatments. This Phase 2 study addresses the urgent need for better therapies for patients with persistent or chronic ITP who have exhausted other options. Participants will receive subcutaneous CM336 using a step-up dosing schedule according to the study protocol. The study plans to enroll 20 to 30 adults who will be monitored over 52 weeks. The treatment aims to reduce harmful antibody-producing cells by targeting BCMA-positive B cells and plasma cells, potentially resetting the immune response responsible for ITP. During the study, participants will undergo regular assessments including platelet count measurements, bleeding evaluations, and antibody testing. Safety will be closely monitored for one year, while efficacy will be assessed at 12 weeks and throughout the study. The research team will track how well CM336 controls platelet levels and reduces the need for emergency treatments, aiming to improve quality of life for those with refractory ITP.
CONDITIONS
Brief Title
An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and above, male or female
- Diagnosed with persistent or chronic immune thrombocytopenia (ITP)
- Previous glucocorticoid therapy was unsuccessful
- In second-line treatment phase, must meet at least one of: no response to thrombopoietin receptor agonists; no sustained response after anti-CD20 or anti-CD38 monoclonal antibody therapy; no response or relapse after splenectomy
- Platelet count below 30 x 10^9/L within 48 hours before first administration
- ECOG physical status score of 2 or less
- Stable maintenance treatment dose for at least 4 weeks before first administration
- Signed and dated informed consent
You will not qualify if you...
- Prior treatment with any anti-BCMA antibody drug
- Presence of autoimmune hemolytic anemia or secondary/hereditary thrombocytopenia
- History of thrombotic or embolic events within 12 months before first dose, or severe bleeding events
- Participation in other drug studies or exposure to study drugs within 4 weeks or 5 half-lives before first dose
- Use of anticoagulants or antiplatelet drugs within 3 weeks before first dose
- Treatment for ITP (e.g., methylprednisolone, platelet transfusion, gamma-globulin, TPO receptor agonists) within 2 weeks before first dose
- Splenectomy within 6 months before first dose
- Use of immunosuppressants or monoclonal antibodies within specified prior timeframes
- Live vaccine within 4 weeks before first dose or planned during trial
- History of allogeneic stem cell or organ transplantation
- Serious diseases limiting participation (e.g., diabetes, severe heart or liver conditions)
- Malignant tumors within 5 years before screening
- History of severe recurrent or chronic infection
- Known or suspected immunosuppression
- Significant lab abnormalities at screening
- Positive HIV or syphilis antibody tests
- Uncontrolled active infections including hepatitis B or C
- Pregnancy or lactation
- Mental disorders preventing informed consent or follow-up
- Unresolved toxicity symptoms from prior treatments
- Other investigator-assessed ineligibility
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 - 12 weeks
Participants receive subcutaneous CM336 by step-up dosing to treat refractory immune thrombocytopenia. This treatment aims to eliminate B cells and plasma cells to reduce pathogenic antibodies and improve platelet count.
Multiple visits for dosing and monitoring during treatment
Duration - up to 40 weeks after treatment
Participants are monitored for safety and efficacy of CM336 treatment, including platelet counts and bleeding assessments.
Regular visits for safety and efficacy assessments up to 52 weeks from treatment start
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
Y
Yunfei Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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