Chemoimmunotherapy with Autologous NK Cell Therapy for Children and Adolescents Aged 18 Months to 18 Years With Refractory or Relapsed High-Risk Neuroblastoma and Ganglioneuroblastoma

What this Trial Is About

Neuroblastoma NB is a serious cancer of the sympathetic nervous system mostly affecting children, with high-risk stage 4 patients facing the poorest outcomes. This trial focuses on patients with refractory disease who respond poorly to initial therapy and those with relapsed or progressive NB. The study aims to improve treatment responses and survival by combining chemotherapy with immunotherapy and natural killer NK cell therapy to overcome drug resistance. The trial has two groups Arm A for patients with refractory disease and Arm B for those with relapsed or progressive disease. Patients in Arm A will undergo an intensified induction phase that includes collection of mononuclear cells to grow autologous NK cells, followed by one course of chemotherapy irinotecan and temozolomide and four courses of combined chemoimmunotherapy with dinutuximab beta and NK cells every 21 days. Arm B patients receive a similar pattern but with five courses of chemoimmunotherapy after blood collection for NK cell preparation. NK cells are transfused on Day 7 of each treatment cycle. Later treatment phases like surgery and radiotherapy occur outside this study. Participants will be monitored for tolerability and side effects immediately after treatment courses. The study tracks response rates, overall survival, event-free survival, progression-free survival, and relapse-free survival at multiple time points up to five years after diagnosis. Patient quality of life is also assessed. The total duration of involvement depends on treatment and follow-up schedules, with detailed clinical and laboratory evaluations throughout the study.

Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Risk Neuroblastoma and Ganglioneuroblastoma