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

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.

Inclusion Criteria:

1. Thrombocytopenia dependent on platelet transfusions and diagnosed with platelet transfusion refractoriness.
2. Presence of one or more kinds of antiplatelet antibodies.
3. Male or female, age≥18 years.
4. The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
5. Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

1. Diagnosed with Idiopathic thrombocytopenic purpura.
2. Platelet transfusion refractoriness caused by non-immune factors.
3. Previously treated with the anti-CD38 monoclonal antibody.
4. Have an allergy to humanized monoclonal antibody or any part of CM313.
5. Pregnant or breastfeeding females, or females planning to become pregnant during the study.
6. Any condition considered to be ineligible for the study by the investigator.