Quadruple Immunotherapy for Neuroblastoma

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hong Kong Children's Hospital
• Collaborator: The University of Hong Kong
• Treatments: Aldesleukin; Dinutuximab; Interleukin-2; Molgramostim; Sargramostim; Spironolactone

Criteria

Inclusion Criteria:

• relapsed or refractory neuroblastoma

• Adequate organ function: creatinine clearance ≥40 ml/min/1.73m2, total bilirubin ≤3 times upper limit of normal and ALT ≤500 IU/L, left ventricular shortening fraction ≥25%, and oxygen saturation ≥92% in room air

• Karnofsky or Lansky performance status score ≥50

• Has an appropriate HLA-haploidentical NK-cell donor available

Exclusion Criteria:

• Pregnant or lactating woman

• HIV infection

• Patients for whom conventional treatment is deemed more appropriate

• Patients who are unlikely to benefit, e.g., terminal malignancy with life expectancy <1 month