Study of CM313(SC) Injection in Subjects With 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
1 other identifier
interventional
110
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
January 24, 2025
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 16, 2027
August 15, 2025
August 1, 2025
2.6 years
January 15, 2025
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AE)
Assess the safety of CM313(SC) injection
Up to 24 weeks
Study Arms (2)
CM313(SC)(low dose group)
EXPERIMENTALCM313(SC)(high dose group)
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Shi
Institute of Hematology & Blood Diseases Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2025
First Posted
January 24, 2025
Study Start
March 25, 2025
Primary Completion (Estimated)
November 16, 2027
Study Completion (Estimated)
November 16, 2027
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share