Aplastic Anemia
Conditions
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
Interventions
BIOLOGICALCM313(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.
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AE) | Up to 52 weeks | Assess the safety and tolerability |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed