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

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

Inclusion Criteria:

1. Diagnosis of idiopathic aplastic anemia.
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:

1. The inherited bone marrow failure syndromes.
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.