CM313 (subcutaneous) injection for 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 trial tests whether a subcutaneous injection of CM313 can safely improve platelet transfusion responses in adults with immune-related platelet transfusion refractoriness.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Keymed Biosciences Co.Ltd (industry)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06792019 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label phase IB/II trial testing two subcutaneous dose levels of CM313 for safety and preliminary efficacy in patients with platelet transfusion refractoriness who have antiplatelet antibodies. Participants are adults with thrombocytopenia dependent on platelet transfusions and an ECOG performance status of 0–2; key exclusions include non-immune causes of refractoriness, prior anti-CD38 therapy, and pregnancy. The trial compares low and high dose CM313 to observe adverse events, tolerability, and early signals of improved post-transfusion platelet counts. The study is being conducted at the Institute of Hematology & Blood Diseases Hospital in Tianjin, China, with outcomes focused on safety and transfusion response measures.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with platelet transfusion dependence due to antiplatelet antibodies, an ECOG score ≤2, and no prior anti-CD38 antibody treatment who can provide informed consent.

Not a fit: Patients whose transfusion refractoriness is caused by non-immune factors, those with idiopathic thrombocytopenic purpura, prior anti-CD38 exposure, or who are pregnant or breastfeeding are unlikely to benefit from this investigational therapy.

Why it matters

Potential benefit: If successful, CM313 could reduce immune-mediated platelet destruction and increase the effectiveness of platelet transfusions for affected patients.

How similar studies have performed: Related anti-CD38 therapies have shown promise in small studies and case reports for immune-mediated platelet refractoriness, offering preliminary support for this approach while CM313 itself remains novel.

Eligibility criteria

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.

Where this trial is running

Tianjin, Tianjin Municipality

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

Study contacts

• Principal investigator: Jun Shi — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Qian Jia

Conditions: Platelet Transfusion Refractoriness