Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
NCT ID: NCT06791824
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
125 participants
INTERVENTIONAL
2025-03-31
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CM313(SC)(low dose group)
CM313(SC) injection
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)(medium dose group)
CM313(SC) injection
Phase IB: CM313(SC) administered at medium dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.
CM313(SC)(high dose group)
CM313(SC) injection
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.
Interventions
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CM313(SC) injection
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
Phase IB: CM313(SC) administered at medium dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.
CM313(SC) injection
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
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Inclusion Criteria
2. Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
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
2. Previously treated with the anti-CD38 monoclonal antibody.
3. Have an allergy to humanized monoclonal antibody or any part of CM313.
4. Pregnant or breastfeeding females, or females planning to become pregnant during the study.
5. Any condition considered to be ineligible for the study by the investigator.
18 Years
ALL
No
Sponsors
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Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jun Shi
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jun Shi
Role: primary
Other Identifiers
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CM313-124101
Identifier Type: -
Identifier Source: org_study_id
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