RecruitingPhase 1NCT06751134

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

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


Sponsor

Nanjing Children's Hospital

Enrollment

12 participants

Start Date

Dec 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy — chimeric natural killer receptor-universal T cells (CNKR-T cells) — for children with neuroblastoma (a childhood cancer of the nervous system) that has come back or stopped responding to standard treatments. This is an innovative approach where engineered immune cells are used to attack the cancer. **You may be eligible if...** - Your child is between 1 and 12 years old and weighs at least 10 kg - Your child has been diagnosed with relapsed or refractory neuroblastoma (cancer that returned after or never responded to standard treatment) - A guardian or the child (if applicable) can sign the informed consent **You may NOT be eligible if...** - Your child is under 1 year old or weighs less than 10 kg - Your child does not have a confirmed diagnosis of relapsed or refractory neuroblastoma - Your child has significant health conditions that would make the cell therapy unsafe - Your child has not received adequate prior standard treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChimeric 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

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NCT06751134


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