Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
A Phase IB/II Clinical Study to Assess the Safety and Preliminary Efficacy of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
Keymed Biosciences Co.Ltd
110 participants
Mar 25, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Thrombocytopenia dependent on platelet transfusions and diagnosed with platelet transfusion refractoriness.
- Presence of one or more kinds of antiplatelet antibodies.
- Male or female, age≥18 years.
- The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
- Willing and able to comply with the requirements for this study and written informed consent.
Exclusion Criteria6
- Diagnosed with Idiopathic thrombocytopenic purpura.
- Platelet transfusion refractoriness caused by non-immune factors.
- Previously treated with the anti-CD38 monoclonal antibody.
- Have an 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 to be ineligible for the study by the investigator.
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Interventions
Phase IB:CM313(SC) administered at low dose according to the protocol. Phase II:CM313(SC) administered at different doses based on Phase IB's results.
Phase IB:CM313(SC) administered at high dose according to the protocol. Phase II:CM313(SC) administered at different doses based on Phase IB's results.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06792019