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Universal CNK-UT Therapy for Refractory aGVHD
Sponsor: First Affiliated Hospital of Zhejiang University
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
Conditions
Interventions
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