Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD

PHASE1RecruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

January 1, 2026

Study Completion Date

August 31, 2026

Conditions
Graft vs Host Disease
Interventions
BIOLOGICAL

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

"OUTLINE: This is a dose-escalation study of CNK-UT cells followed by a dose-expansion study.~1. Dose Escalation (Single Ascending Dose Study, SAD): During SAD study stage, the participants will be intravenous infused with CNK-UT cells (1\~10×10\^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.~2. Dose Expansion (multiple ascending dose study, MAD): During MAD study stage, the participants will receive multiple doses of CNK-UT cells. The dosage and frequency of drug administration in the dose expansion stage can be adjusted and determined according to the SAD study."

Trial Locations (1)

Unknown

RECRUITING

First Affiliated Hospital of Fujian Medical University, Fuzhou

All Listed Sponsors
lead

Fujian Medical University

OTHER