Quadruple Immunotherapy for Neuroblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 18 Years
Gender	All

More Inclusion & Exclusion 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 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05754684
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hong Kong Children's Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Daniel Cheuk
Principal Investigator Affiliation	Hong Kong Children's Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Hong Kong
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma Recurrent

Additional Details

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 started orally on day -1, given three times daily till cessation of GM-CSF. Alternative anti-GD2 antibody (Naxitamab) can be used instead of dinutuximab, to be given on day -5, day -3, day +1 and day +3.

Arms & Interventions

Arms

Experimental: Intervention

Quadruple immunotherapy

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hong Kong Children's Hospital, Hong Kong, Hong Kong

Status

Recruiting

Address

Hong Kong Children's Hospital

Hong Kong, ,

Site Contact

Daniel Cheuk

[email protected]

851-35136049

Clinical Trial Finder