RecruitingPhase 1/2

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

China110 participantsStarted 2025-03-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Adverse events (AE)

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT06792019

SponsorKeymed Biosciences Co.Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-16

Contact for this trial

Qian Jia

028-88610620 qianjia@keymedbio.com

View on ClinicalTrials.gov More Platelet Transfusion Refractoriness trials