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

August 11, 2025 updated by: Keymed Biosciences Co.Ltd

A Phase IB/II Clinical Study to Assess the Safety and Preliminary Efficacy 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital
        • Contact:
          • Jun Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CM313(SC)(low dose group)
Biological: CM313(SC) injection-low dose
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.
Experimental: CM313(SC)(high dose group)
Biological: CM313(SC) injection-high dose
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AE)
Time Frame: Up to 24 weeks
Assess the safety of CM313(SC) injection
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Jun Shi, Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

November 16, 2027

Study Completion (Estimated)

November 16, 2027

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CM313-124102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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