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RECRUITING
NCT06568328
PHASE1

Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD

Sponsor: Fujian Medical University

View on ClinicalTrials.gov

Summary

This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory/resistant or steroid-dependent GVHD.

Official title: A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of CNK-UT Cells to Treat the Patients With Steroid-refractory/Resistant or Steroid-dependent GVHD

Key Details

Gender

All

Age Range

1 Year - 70 Years

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2024-09-01

Completion Date

2026-08-31

Last Updated

2024-08-23

Healthy Volunteers

No

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 a"3 +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.

Locations (1)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China