Universal CNK-UT Therapy for Refractory aGVHD

PHASE1RecruitingINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

December 14, 2024

Primary Completion Date

December 14, 2025

Study Completion Date

June 30, 2026

Conditions
Acute Graft-versus-Host Disease
Interventions
BIOLOGICAL

Chimeric Natural Killer Receptor Universal T-cells (CNK-UT)

"Dose Escalation (Single Ascending Dose Study, SAD): During SAD study stage, the participants will be intravenous infused with CNK-UT cells (3×10\^7 CNK+ cells/kg)with a3 +3 design to determine the maximum tolerated dose. During single ascending dose (SAD) study stage, the participants will receive a single dose of CNK-UT cells before the DLT observation period (21 days). If the participants do not experience DLT, they will be able to enter a multiple ascending dose (MAD) study stage.~Dose Expansion (multiple ascending dose study, MAD): During MAD study stage, the participants will receive multiple doses of CNK-UT cells(6-10×10\^7 CNK+ cells/kg). The dosage and frequency of drug administration in the dose expansion stage can be adjusted and determined according to the SAD study."

Trial Locations (2)

310000

RECRUITING

The first affiliated hospital of zhejiang university, school of medicine., Hangzhou

Unknown

RECRUITING

First Affiliated Hospital of Fujian Medical University, Fuzhou

All Listed Sponsors
collaborator

ST Phi Therapeutics Co., Ltd

UNKNOWN

lead

First Affiliated Hospital of Zhejiang University

OTHER