Phase 1 Study of CNK-UT Cells to Treat Children Aged 1 to 12 Years with Relapsed or Refractory Neuroblastoma

What this Trial Is About

Researchers are evaluating the safety, preliminary effectiveness, and how the body processes universal T-cells engineered with a chimeric natural killer receptor CNK-UT in children aged 1 to 12 years with relapsed or refractory Neuroblastoma. This phase I, single-arm, open-label pilot study aims to understand the potential of CNK-UT cell therapy in treating this challenging condition where cancer has returned or not responded to standard treatments. Participants will receive CNK-UT cells through intravenous infusion. The study begins with a dose escalation phase where a single dose of CNK-UT cells ranging from 3 to 34 million CNK cells per kilogram of body weight is given to determine the highest safe dose. If no serious side effects occur, participants enter the dose expansion phase, where multiple doses are administered based on prior results. The dosing schedule and frequency in this phase are adjusted according to findings from the initial stage. Throughout the study, children will be monitored for treatment-related side effects for up to one year. Researchers will assess tumor responses using imaging and bone marrow tests, measure disease control, progression-free survival, and overall survival. They will also study how the CNK-UT cells behave in the body over time. Participants will undergo laboratory tests and functional assessments to ensure organ function and safety during the trial, which is expected to last up to a year of follow-up.

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