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Quadruple Immunotherapy for Neuroblastoma

NCT05754684 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

  • Neuroblastoma Recurrent

Interventions

BIOLOGICAL

Natural killer cell

Natural killer cells isolated from HLA-haploidentical relative donor

DRUG

Dinutuximab beta

Dinutuximab beta iv for 5 days

DRUG

Interleukin-2

Interleukin-2 sc alternate day for 6 doses

DRUG

Granulocyte-Macrophage Colony-Stimulating Factor

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

DRUG

Spironolactone

Spironolactone po three time daily

DRUG

Naxitamab

Naxitamab iv for 4 days (as alternative for dinutuximab)

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER

  • Hong Kong Children's Hospital

    lead OTHER

Principal Investigators

  • Daniel Cheuk · Hong Kong Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754684 on ClinicalTrials.gov