Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
Key facts
- Phase
- Phase 1/2
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Keymed Biosciences Co.Ltd
- Trial code
- NCT06791824
- Record updated
- 18 February 2025
- Original description
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 anemiaRead full original descriptionShow less
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: 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.
Exclusion: Previously treated with the anti-CD38 monoclonal antibody; The inherited bone marrow failure syndromes; Have an allergy to humanized monoclonal antibody or any part of CM313; Any condition considered to be ineligible for the study by the investigator; Pregnant or breastfeeding females, or females planning to become pregnant during the study.