Quadruple Immunotherapy for Neuroblastoma

Phase 2

Recruiting

• Conditions: Neuroblastoma Recurrent
• Interventions: Biological: Natural killer cell; Drug: Dinutuximab beta; Drug: Interleukin-2; Drug: Granulocyte-Macrophage Colony-Stimulating Factor; Drug: Spironolactone; Drug: Naxitamab

• Registration Number: NCT05754684
• Lead Sponsor: Hong Kong Children's Hospital

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 neu...

Detailed Description

Included patients will receive intravenous infusion of donor NK cells on day 0, and anti-GD2 antibody (dinutuximab) on day -6 to day -2. IL-2 will be given subcutaneously on day -1, day +1, day +3, day +5, day +7, and day +9. Subcutaneous injection of GM-CSF will be started on day 0, given daily till neutrophil count \>1000/mm3. Spironolactone will be starte...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Granulocyte-Macrophage Colony-Stimulating Factor	Quadruple immunotherapy
Intervention	Spironolactone	Quadruple immunotherapy
Intervention	Naxitamab	Quadruple immunotherapy
Intervention	Dinutuximab beta	Quadruple immunotherapy
Intervention	Interleukin-2	Quadruple immunotherapy
Intervention	Natural killer cell	Quadruple immunotherapy

Primary Outcome Measures

Name	Time	Method
Proportion of patients who have objective response in the tumor	1-2 months	Objective response = complete response + partial response + minor response + stable disease

Secondary Outcome Measures

Name	Time	Method
Overall survival at 1 year	up to 1 year	From the date of treatment start until the date of death from any cause, assessed up to 1 year
Percentage of donor NK cells	up to 1 year	Percentage of donor natural killer cells in the recipient's blood will be evaluated weekly from the date of NK cell infusion for 4 weeks, then every 2 weeks till donor NK cells are undetectable
Progression-free survival	up to 1 year	From date of treatment start until the date of first documented progression or the date of death from any cause, whichever comes first, assessed up to 1 year
Proportion of patients who have tumor relapse	up to 1 year	relapse = reappearance of tumor after complete response
Number of patients who experience adverse events	up to 1 month	Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)

Trial Locations

Locations (1)

Hong Kong Children&#39;s Hospital; 🇭🇰 Hong Kong, Hong Kong