Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness

Phase 1

Recruiting

• Conditions: Platelet Transfusion Refractoriness
• Interventions: Biological: CM313(SC) injection-low dose; Biological: CM313(SC) injection-high dose

• Registration Number: NCT06792019
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This is a randomized, open-label, phase IB/II clinical study to evaluate the safety and preliminary efficacy of CM313(SC) injection in patients with Platelet Transfusion Refractoriness.

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
• Study Start: 2025-03-25
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-15
• Primary Completion: 2027-11-16
• Study Completion: 2027-11-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Thrombocytopenia dependent on platelet transfusions and diagnosed with platelet transfusion refractoriness.
2. Presence of one or more kinds of antiplatelet antibodies.
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. Diagnosed with Idiopathic thrombocytopenic purpura.
2. Platelet transfusion refractoriness caused by non-immune factors.
3. Previously treated with the anti-CD38 monoclonal antibody.
4. Have an allergy to humanized monoclonal antibody or any part of CM313.
5. Pregnant or breastfeeding females, or females planning to become pregnant during the study.
6. 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-low dose	-
CM313(SC)(high dose group)	CM313(SC) injection-high dose	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AE)	Up to 24 weeks	Assess the safety of CM313(SC) injection

Trial Locations

Locations (1)

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