This is a prospective, single-arm, open, single-center clinical trial to evaluate the safety and efficacy of autologous NK cells combined with chemotherapy and GD2 monoclonal antibody in the treatment of newly diagnosed high-risk or relapsed/refractory neuroblastoma in children. Fifteen eligible subjects are planned to be included. The objective is to evaluate the safety and efficacy of autologous NK cells combined with GD2 monoclonal antibody in the treatment of children with newly diagnosed high-risk or relapsed/refractory neuroblastoma, which is expected to be safe and effective in improving PFS and DCR in children with refractory/recurrent neuroblastoma.
Age 1-18 years (including 18 years), gender not restricted;
Diagnosed with high-risk neuroblastoma and meeting the following conditions: high-risk neuroblastoma has undergone standardized treatment including induction therapy and consolidation therapy according to COG, SIOPEN or the expert consensus CCCG-NB-2021, and has entered the maintenance stage; high-risk neuroblastoma has undergone induction therapy with COG chemotherapy combined with GD2 immunotherapy and has entered the maintenance stage; any recurrence of high-risk neuroblastoma after standardized treatment; or the disease is initially determined to be in a refractory state.
If it is relapsed/refractory neuroblastoma, there must be at least one measurable lesion according to RECIST 1.1 criteria;
Uncontrollable active infections, or expected to receive systemic anti-infection or immunosuppressive therapy during participation in this trial;
Any toxic reactions caused by previous anti-tumor treatments have not recovered to grade 1 or below (CTCAE 5.0 version) (hair loss is not restricted);
Have a history of organ transplantation or are expected to undergo organ transplantation during the trial period;
Highly allergic constitution;