NCT05754684 Quadruple Immunotherapy for Neuroblastoma
| NCT ID | NCT05754684 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hong Kong Children's Hospital |
| Condition | Neuroblastoma Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 29 participants in total. It began in 2022-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 neuroblastoma.
Eligibility 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
Contact & Investigator
Daniel Cheuk
PRINCIPAL INVESTIGATOR
Hong Kong Children's Hospital
Frequently Asked Questions
Who can join the NCT05754684 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Neuroblastoma Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05754684 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05754684 currently recruiting?
Yes, NCT05754684 is actively recruiting participants. Contact the research team at cheukkld@gmail.com for enrollment information.
Where is the NCT05754684 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT05754684 clinical trial?
NCT05754684 is sponsored by Hong Kong Children's Hospital. The principal investigator is Daniel Cheuk at Hong Kong Children's Hospital. The trial plans to enroll 29 participants.