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RECRUITING
NCT06751134
PHASE1

Chimeric Natural Killer Receptor-Universal T Cells for Relapsed or Refractory Neuroblastoma

Sponsor: Nanjing Children's Hospital

View on ClinicalTrials.gov

Summary

This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, preliminary efficacy, pharmacokinetics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with relapsed/refractory Neuroblastoma.

Official title: A Study to Evaluate the Safety, Preliminary Efficacy, Pharmacokinetics of CNK-UT Cells to Treat the Patients with Relapsed/refractory Neuroblastoma

Key Details

Gender

All

Age Range

1 Year - 12 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-12-28

Completion Date

2026-12-01

Last Updated

2025-02-07

Healthy Volunteers

No

Interventions

DRUG

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 (3\~34×10\^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 (2)

Nanjing Children's Hospital

Nanjing, Jiangsu, China

Nanjing

Nanjing, Jiangsu, China