NCT05754684

Quadruple Immunotherapy for Neuroblastoma

Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Hong Kong Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroblastoma Recurrent

Interventions

Type	Name	Description
BIOLOGICAL	Natural killer cell	Natural killer cells isolated from HLA-haploidentical relative donor
DRUG	Dinutuximab beta	Dinutuximab beta iv for 5 days
DRUG	Interleukin-2	Interleukin-2 sc alternate day for 6 doses
DRUG	Granulocyte-Macrophage Colony-Stimulating Factor	Granulocyte-macrophage colony-stimulating factor sc daily till ANC \>2,000/mm3
DRUG	Spironolactone	Spironolactone po three time daily
DRUG	Naxitamab	Naxitamab iv for 4 days (as alternative for dinutuximab)

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-03-06
• Last updated: 2025-09-15

Locations

1 site across 1 country: Hong Kong