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Universal CNK-UT Therapy for Refractory aGVHD

NCT06750133 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

  • Acute Graft-versus-Host Disease

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.

Sponsors & Collaborators

  • ST Phi Therapeutics Co., Ltd

    collaborator UNKNOWN

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • He Huang, PHD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-14
Primary Completion
2025-12-14
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750133 on ClinicalTrials.gov