NCT05754684

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 15, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

November 18, 2022

Last Update Submit

September 8, 2025

Conditions

Neuroblastoma Recurrent

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who have objective response in the tumor

    Objective response = complete response + partial response + minor response + stable disease

    1-2 months

Secondary Outcomes (5)

  • Overall survival at 1 year

    up to 1 year

  • Progression-free survival

    up to 1 year

  • Proportion of patients who have tumor relapse

    up to 1 year

  • Number of patients who experience adverse events

    up to 1 month

  • Percentage of donor NK cells

    up to 1 year

Study Arms (1)

Intervention

EXPERIMENTAL

Quadruple immunotherapy

Biological: Natural killer cellDrug: Dinutuximab betaDrug: Interleukin-2Drug: Granulocyte-Macrophage Colony-Stimulating FactorDrug: SpironolactoneDrug: Naxitamab

Interventions

Natural killer cellBIOLOGICAL

Natural killer cells isolated from HLA-haploidentical relative donor

Also known as: NK cell
Intervention
Dinutuximab betaDRUG

Dinutuximab beta iv for 5 days

Also known as: Ch14.18
Intervention
Interleukin-2DRUG

Interleukin-2 sc alternate day for 6 doses

Also known as: Aldesleukin
Intervention
Granulocyte-Macrophage Colony-Stimulating FactorDRUG

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

Also known as: Sargramostim
Intervention
SpironolactoneDRUG

Spironolactone po three time daily

Also known as: Aldactone
Intervention
NaxitamabDRUG

Naxitamab iv for 4 days (as alternative for dinutuximab)

Also known as: hu3F8
Intervention

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Children&#39;s Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

dinutuximabInterleukin-2aldesleukinGranulocyte-Macrophage Colony-Stimulating FactorsargramostimSpironolactonenaxitamab

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological FactorsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsLactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Daniel Cheuk

    Hong Kong Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Cheuk

CONTACT

852-35136049cheukkld@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

November 18, 2022

First Posted

March 6, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 15, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)