Quadruple immunotherapy for treating relapsed neuroblastoma in children
Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
PHASE2 · Hong Kong Children's Hospital · NCT05754684
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Hong Kong Children's Hospital (other) |
| Drugs / interventions | immunotherapy, dinutuximab, Naxitamab |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05754684 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients diagnosed with relapsed or refractory neuroblastoma who have an appropriate NK-cell donor available.
Not a fit: Patients with terminal malignancies and a life expectancy of less than one month are unlikely to benefit from this study.
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 performed: While the approach of using quadruple immunotherapy is innovative, similar studies involving immunotherapy for neuroblastoma have shown promising results, indicating potential for success.
Eligibility criteria
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 this trial is running
Hong Kong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuroblastoma Recurrent