Quadruple immunotherapy for treating relapsed neuroblastoma in children
Official title: Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
Run by Hong Kong Children's Hospital · NCT05754684 · Data updated 2026-11-12
This study is testing a new combination of treatments to see if it can help children with relapsed neuroblastoma feel better and fight their cancer more effectively.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 29 (estimated) |
| Sponsor | Hong Kong Children's Hospital Academic / other |
| Drugs / interventions | immunotherapy, dinutuximab, Naxitamab |
| Locations | 1 site (Hong Kong) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT05754684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pediatric patients diagnosed with relapsed or refractory neuroblastoma who have an appropriate NK-cell donor available.
✕Probably not a fit
Patients with terminal malignancies and a life expectancy of less than one month are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and efficacy of a quadruple immunotherapy approach for pediatric patients with relapsed or refractory neuroblastoma. Participants will receive a combination of natural killer (NK) cells, anti-GD2 antibodies, cytokines (IL-2 and GM-CSF), and a retinoid X receptor gamma agonist, spironolactone. The treatment regimen includes intravenous and subcutaneous infusions over a specified timeline to enhance the immune response against the cancer. The study aims to determine if this innovative combination can improve outcomes for children facing this challenging condition.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children with relapsed neuroblastoma, potentially improving survival rates.
How similar studies have gone: While the approach of using quadruple immunotherapy is innovative, similar studies involving immunotherapy for neuroblastoma have shown promising results, indicating potential for success.
Who can join: the full rules
Show full 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
Where it's running
-
Hong Kong Children's Hospital
Hong Kong, Hong Kong Recruiting
Study contacts
- Principal investigator: Daniel Cheuk — Hong Kong Children's Hospital
- Study coordinator: Daniel Cheuk
- Email: cheukkld@gmail.com
- Phone: 852-35136049
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adding N-803 to chemoimmunotherapy for relapsed or refractory neuroblastoma
This study tests whether adding the immune stimulant N-803 to a chemoimmunotherapy regimen helps children and young adults with relapsed or refractory neuroblastoma.
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Prolonged Naxitamab with irinotecan, temozolomide, and sargramostim for relapsed or refractory neuroblastoma
This trial will test whether giving the immunotherapy Naxitamab more slowly, along with irinotecan, temozolomide, and sargramostim, reduces infusion side effects for people with relapsed or refractory neuroblastoma.
-
Combining Lutathera® and Olaparib for treating recurrent solid tumors in children and adolescents
This study is testing if combining Lutathera® with olaparib can help children and teenagers with hard-to-treat solid tumors that have certain receptors.
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177Lu-DOTATATE treatment for children with high-risk neuroblastoma
This study is testing a new treatment called 177Lu-DOTATATE to see if it can help children with high-risk neuroblastoma that has come back or worsened.
-
Using engineered T-cells to treat relapsed or refractory neuroblastoma in children
This study is testing a new type of engineered T-cell treatment for children with relapsed or hard-to-treat neuroblastoma to see if it can help fight their cancer.
-
Using NK cells to treat high-risk neuroblastoma in children
This study is testing if injections of special immune cells can help children aged 2 to 16 with tough-to-treat neuroblastoma feel better and improve their chances of recovery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.