Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754684
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2022-11-18
Brief Title:
Quadruple Immunotherapy for Neuroblastoma
Sponsor:
Hong Kong Childrens Hospital
Organization:
Hong Kong Childrens Hospital
Study Overview
Official Title:
Quadruple Immunotherapy for Paediatric Patients with Relapsed or Refractory Neuroblastoma
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1000mm3 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
Alternative anti-GD2 antibody Naxitamab can be used instead of dinutuximab to be given on day -5 day -3 day 1 and day 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None