Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
A Phase IB/II Clinical Study to Assess the Safety, Tolerability and Preliminary Efficacy of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
1 other identifier
interventional
125
1 country
1
Brief Summary
This is a randomized, open-label, phase IB/II clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed/refractory aplastic anemia
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 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 18, 2025
February 1, 2025
2.8 years
January 15, 2025
February 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AE)
Assess the safety and tolerability
Up to 52 weeks
Study Arms (3)
CM313(SC)(low dose group)
EXPERIMENTALCM313(SC)(medium 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.
Eligibility Criteria
You may qualify if:
- Diagnosis of idiopathic aplastic anemia.
- Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
- 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:
- The inherited bone marrow failure syndromes.
- 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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 1, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 18, 2025
Record last verified: 2025-02