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Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
Sponsor: Fujian Medical 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 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
Conditions
Interventions
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