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

Phase 1

Not yet recruiting

• Conditions: Aplastic Anemia
• Interventions: Biological: CM313(SC) injection

• Registration Number: NCT06791824
• Lead Sponsor: Keymed Biosciences Co.Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-19
• Study First Posted: 2025-01-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Study Start: 2025-03
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CM313(SC)(low dose group)	CM313(SC) injection	-
CM313(SC)(medium dose group)	CM313(SC) injection	-
CM313(SC)(high dose group)	CM313(SC) injection	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AE)	Up to 52 weeks	Assess the safety and tolerability

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China