Actively Recruiting
Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
Led by Keymed Biosciences Co.Ltd · Updated on 2025-08-15
110
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, open-label, phase IB/II clinical study to evaluate the safety and preliminary efficacy of CM313(SC) injection in patients with Platelet Transfusion Refractoriness.
CONDITIONS
Official Title
Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Thrombocytopenia dependent on platelet transfusions diagnosed with platelet transfusion refractoriness
- Presence of one or more kinds of antiplatelet antibodies
- Male or female, age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) physical status score 2 or less
- Willing and able to comply with study requirements and provide written informed consent
You will not qualify if you...
- Diagnosed with Idiopathic thrombocytopenic purpura
- Platelet transfusion refractoriness caused by non-immune factors
- Previously treated with the anti-CD38 monoclonal antibody
- Allergy to humanized monoclonal antibody or any part of CM313
- Pregnant or breastfeeding females, or females planning to become pregnant during the study
- Any condition considered ineligible by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
Q
Qian Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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