Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeymed Biosciences Co.Ltd

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CM313(SC) injection-low dose
  • CM313(SC) injection-high dose

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators