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RECRUITING
NCT06792019
PHASE1/PHASE2

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

Sponsor: Keymed Biosciences Co.Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-03-25

Completion Date

2027-11-16

Last Updated

2025-08-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China