RecruitingPhase 2NCT05754684

Quadruple Immunotherapy for Neuroblastoma

Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma


Sponsor

Hong Kong Children's Hospital

Enrollment

29 participants

Start Date

Jan 1, 2022

Study Type

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

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a four-part immunotherapy combination for children with neuroblastoma (a childhood cancer of the nervous system) that has relapsed (come back) or stopped responding to treatment, using natural killer (NK) cells from a partially matched donor along with other immune-boosting drugs. **You may be eligible if...** - You (or your child) have relapsed or refractory neuroblastoma - Organ function meets the required levels (kidneys, liver, heart, oxygen levels) - A suitable half-matched NK cell donor is available - Performance status is sufficient for treatment (Karnofsky or Lansky score ≥50) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have HIV - Conventional treatment options are still available and expected to be curative - Organ function does not meet the required minimums Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNatural killer cell

Natural killer cells isolated from HLA-haploidentical relative donor

DRUGDinutuximab beta

Dinutuximab beta iv for 5 days

DRUGInterleukin-2

Interleukin-2 sc alternate day for 6 doses

DRUGGranulocyte-Macrophage Colony-Stimulating Factor

Granulocyte-macrophage colony-stimulating factor sc daily till ANC \>2,000/mm3

DRUGSpironolactone

Spironolactone po three time daily

DRUGNaxitamab

Naxitamab iv for 4 days (as alternative for dinutuximab)


Locations(1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

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NCT05754684


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