Quadruple Immunotherapy for Neuroblastoma
ConditionNeuroblastoma Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorHong Kong Children's Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Natural killer cell
- Dinutuximab beta
- Interleukin-2
- Granulocyte-Macrophage Colony-Stimulating Factor
- Spironolactone
- Naxitamab
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
Hong Kong Children's Hospital
Lead sponsor
The University of Hong Kong
Collaborator
Source ClinicalTrials.gov