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NCT Number: NCT06792019

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

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.

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Key information

Conditions

Platelet Transfusion Refractoriness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Jun Shi

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM313(SC) injection-low dose

Biological

Phase IB:CM313(SC) administered at low dose according to the protocol. Phase II:CM313(SC) administered at different doses based on Phase IB's results.

CM313(SC) injection-high dose

Biological

Phase IB:CM313(SC) administered at high dose according to the protocol. Phase II:CM313(SC) administered at different doses based on Phase IB's results.

Primary outcomes

  1. Adverse events (AE)

    Time frame: Up to 24 weeks

    Assess the safety of CM313(SC) injection

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Phase IB/II Clinical Study to Assess the Safety and Preliminary Efficacy of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 24, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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