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.
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.
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.
Parallel
CM313(SC) injection-low dose
Biological/VaccinePhase 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.
CM313(SC) injection-high dose
Biological/VaccinePhase 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.
Adverse events (AE)
Assess the safety of CM313(SC) injection
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