Spots Global Cancer Trial Database for Quadruple Immunotherapy for Neuroblastoma

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Trial Identification

Brief Title: Quadruple Immunotherapy for Neuroblastoma

Official Title: Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma

Study ID: NCT05754684

Conditions

Neuroblastoma Recurrent

Interventions

Natural killer cell

Dinutuximab beta

Interleukin-2

Granulocyte-Macrophage Colony-Stimulating Factor

Spironolactone

Naxitamab

Study Description

Brief Summary: This is a single-arm clinical trial to evaluate the efficacy and safety of quadruple immunotherapy with natural killer (NK) cells, anti-GD2 antibody, cytokines (interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF)) and retinoid X receptor gamma (RXRg) agonist spironolactone for paediatric patients with relapsed or refractory neuroblastoma.

Detailed Description: Included patients will receive intravenous infusion of donor NK cells on day 0, and anti-GD2 antibody (dinutuximab) on day -6 to day -2. IL-2 will be given subcutaneously on day -1, day +1, day +3, day +5, day +7, and day +9. Subcutaneous injection of GM-CSF will be started on day 0, given daily till neutrophil count \>1000/mm3. Spironolactone will be started orally on day -1, given three times daily till cessation of GM-CSF. Alternative anti-GD2 antibody (Naxitamab) can be used instead of dinutuximab, to be given on day -5, day -3, day +1 and day +3.