Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
ConditionAplastic Anemia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeymed Biosciences Co.Ltd
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CM313(SC) injection
- CM313(SC) injection
- CM313(SC) injection
Treatment groups
125 Participants
are divided into 3 treatment groupsLocations
1Institute of Hematology & Blood Diseases Hospital TianjinTianjin Municipality, China
Sponsors and collaborators
Keymed Biosciences Co.Ltd
Lead sponsor
Source ClinicalTrials.gov