CM313 (subcutaneous) injection for platelet transfusion refractoriness
Official title: A Phase IB/II Clinical Study to Assess the Safety and Preliminary Efficacy of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
Run by Keymed Biosciences Co.Ltd · NCT06792019 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | November 16, 2027 |
| Study ends | November 16, 2027 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT06792019 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: qianjia@keymedbio.com
- Phone: 028-88610620
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using Rituximab to treat severe aplastic anemia with platelet transfusion issues
This study is testing if rituximab can help people with severe aplastic anemia who have trouble getting enough platelets from transfusions.
-
Single-dose CM383 in healthy adult men
This trial will test a single dose of CM383 given by IV infusion or subcutaneous injection in healthy adult men to see how the drug is processed, whether it triggers immune responses, and if it is safe.
-
Long-term safety and efficacy of CM512 for atopic dermatitis
This open-label follow-up will test whether continuing CM512 is safe and helps people with atopic dermatitis who finished a parent CM512 study.
-
Single intravenous CM559 dosing in healthy adult men
This trial tests single intravenous doses of CM559 to see if they are safe and how the drug is processed in healthy men aged 18–60.
-
CM336 treatment for relapsed or refractory autoimmune cytopenia
This trial will test whether CM336, a BCMA/CD3 bispecific antibody given by injection, can help adults with relapsed or refractory autoimmune cytopenias such as ITP, AIHA, or Evans syndrome.
-
CM512 injection for adults with chronic spontaneous urticaria
This study will test whether injections of CM512 reduce hives and itching in adults with chronic spontaneous urticaria who still have symptoms despite second-generation H1‑antihistamines.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.