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RECRUITING
NCT06750133
PHASE1

Universal CNK-UT Therapy for Refractory aGVHD

Sponsor: First Affiliated Hospital of Zhejiang 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 aGVHD.

Official title: A Study of Universal CNK-UT Cell Injection in Patients With Refractory Acute Graft-versus-host Disease

Key Details

Gender

All

Age Range

14 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2024-12-14

Completion Date

2026-06-30

Last Updated

2024-12-27

Healthy Volunteers

No

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 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. 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.

Locations (2)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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

Hangzhou, Zhejiang, China