Study of Safety and Effectiveness of Injected Donor NK Cells for Children Aged 2 to 16 with Recurrent or Refractory High-Risk Neuroblastoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of systemic injections of allogenic natural killer NK cells in children with refractory or recurrent high-risk neuroblastoma. This study compares the group receiving NK cell infusions with a control group undergoing conventional treatment to determine if the new intervention is safe and effective for this challenging condition. The trial is in phase 1 and focuses on patients aged 2 to 16 years who have not responded to standard therapies. The NK cells used in this study are collected from healthy donors through a process called apheresis and purified using a specialized device in a clean room. After quality checks, the cells are stored at very low temperatures until needed. Participants receive three injections of these NK cells, dosed at 5 million cells per kilogram of body weight, administered intravenously 7 to 10 days after each chemotherapy course. Depending on how the patient responds and recovers, two additional injections may be given if improvement is confirmed by MRI MIBG scans. During the study, children will be monitored for safety after each NK cell infusion and compared to those receiving conventional treatments. Researchers will assess response rates at 6 and 12 months after treatment. Evaluations include imaging studies such as MRI and PET scans, laboratory tests, and clinical assessments. Participation involves multiple injections over chemotherapy intervals, with follow-up to track safety and treatment effects. The trial is expected to continue until November 2026.

Safety and Efficacy of Systemic Allogenic NK Cells in R/R Neuroblastoma