Quadruple Immunotherapy for Neuroblastoma
Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
Hong Kong Children's Hospital
29 participants
Jan 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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
Interventions
Natural killer cells isolated from HLA-haploidentical relative donor
Dinutuximab beta iv for 5 days
Interleukin-2 sc alternate day for 6 doses
Granulocyte-macrophage colony-stimulating factor sc daily till ANC \>2,000/mm3
Spironolactone po three time daily
Naxitamab iv for 4 days (as alternative for dinutuximab)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05754684