Study of Universal CNK-UT Cell Therapy for Patients Aged 14 to 70 With Steroid-Refractory or Steroid-Dependent Acute Graft-versus-Host Disease After Stem Cell Transplant

What this Trial Is About

Researchers are studying universal T-cells engineered with a chimeric natural killer receptor CNK-UT to treat patients with steroid-refractory, resistant, or steroid-dependent acute graft-versus-host disease aGVHD following allogeneic hematopoietic stem cell transplantation. This pilot, open-label, multi-center study aims to evaluate the safety, tolerability, effectiveness, and how the treatment behaves in the body. The trial is led by the First Affiliated Hospital of Zhejiang University and focuses on patients aged 14 to 70 years. The study involves two key phases dose escalation and dose expansion. In the dose escalation phase, participants receive a single intravenous injection of CNK-UT cells at a dose of 3 x 107 CNK cells per kilogram of body weight to find the maximum tolerated dose and observe any dose-limiting toxicities within 21 days. If safe, participants may enter the dose expansion phase where multiple doses of CNK-UT cells 6 to 10 x 107 CNK cellskg are given. The dosage and frequency during this phase are adjusted based on findings from the dose escalation phase. Participants will be closely monitored for up to one year to assess treatment-related adverse events, response rates, progression-free survival, overall survival, and pharmacokinetics of the CNK-UT cells. Assessments include physical exams, laboratory tests, and blood analysis to track immune cell levels and drug behavior. The study also measures how long responses last and overall treatment effects through six months of follow-up. Participants will be required to attend scheduled visits for these evaluations during the study period.

Universal CNK-UT Therapy for Refractory aGVHD