Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Hong Kong Special Administrative Region
Hong Kong Children's Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Daniel Cheuk
cheukkld@gmail.com
852-35136049
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 29
Treatments
Experimental: Intervention
Quadruple immunotherapy
Related Therapeutic Areas
Sponsors
Collaborators: The University of Hong Kong
Leads: Hong Kong Children's Hospital