Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia

Launched by KEYMED BIOSCIENCES CO.LTD · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CM313(SC) injection for patients with relapsed or refractory aplastic anemia, a serious condition where the bone marrow does not make enough blood cells. The goal is to find out if this treatment is safe, tolerable, and effective for helping people with this condition. The study is in its early stages and is not yet recruiting participants.

To participate in this trial, patients must be at least 18 years old and have a diagnosis of idiopathic aplastic anemia that has not responded to previous treatments. Participants should be in good physical condition, meaning they can manage daily activities without too much difficulty. Women who are pregnant or breastfeeding, as well as those with certain allergies or other medical conditions, may not be eligible. If you qualify and decide to join the trial, you will receive the CM313(SC) injection and be monitored closely by the medical team for any side effects or changes in your condition.

Gender

ALL

Eligibility criteria

• 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.