No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
Up to 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
29 (estimated)
Sponsor
Hong Kong Children's Hospital · Other
Who this trial is looking for
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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.
Trial Locations
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Facility
City
State
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Status
Eligibility 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 per…
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
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