NCT06792019

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

A Phase IB/II Clinical Study to Assess the Safety and Preliminary Efficacy of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Platelet Transfusion Refractoriness

Interventions

Type	Name	Description
BIOLOGICAL	CM313(SC) injection-low dose	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.
BIOLOGICAL	CM313(SC) injection-high dose	Phase IB:CM313(SC) administered at high dose according to the protocol. Phase II:CM313(SC) administered at different doses based on Phase IB's results.

Timeline

• Start date: 2025-03-25
• Primary completion: 2027-11-16
• Completion: 2027-11-16
• First posted: 2025-01-24
• Last updated: 2025-08-15

Locations

1 site across 1 country: China