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

Recruiting now · Phase 1/Phase 2

Conditions studied: Platelet Transfusion Refractoriness

In brief

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.

Key facts

Study ID

NCT06792019

Run by

Keymed Biosciences Co.Ltd

People needed

110

Starts

2025-03-25

Expected to finish

2027-11-16

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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