Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631391
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Phase I Study of Umbilical Cord Blood Natural Killer NK Cell Therapy for Children With High-risk RR Neuroblastoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study of Umbilical Cord Blood Natural Killer NK Cell Therapy for Pediatric Neuroblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neuroblastoma is the most common extracranial solid tumor with more than half of the patients diagnosed at the metastatic stage classified as high-risk High-risk neuroblastoma has a poor prognosis and low survival rate Despite treatment with induction consolidation and maintenance therapy including GD2 monoclonal antibody the survival rate is only about 60 and many patients still relapse progress and die
NK cell therapy is an emerging immunotherapy that can effectively inhibit and kill tumor cells without significant adverse reactions reducing the risk of tumor recurrence and metastasis and improving patients immunity and quality of life Its safety has been widely recognized Currently clinical trials of NK cell infusion therapy for neuroblastoma patients are ongoing and NK cell-based immunotherapy holds great clinical promise for neuroblastoma We plan to conduct a phase I clinical trial on umbilical cord blood NK cell therapy for high-risk recurrentrefractory neuroblastoma in children to determine the maximum tolerated dose of umbilical cord blood NK cell therapy in these patients thereby laying the foundation for future combination therapies and phase II and III clinical studies
NK cell therapy is an emerging immunotherapy that can effectively inhibit and kill tumor cells without significant adverse reactions reducing the risk of tumor recurrence and metastasis and improving patients immunity and quality of life Its safety has been widely recognized Currently clinical trials of NK cell infusion therapy for neuroblastoma patients are ongoing and NK cell-based immunotherapy holds great clinical promise for neuroblastoma We plan to conduct a phase I clinical trial on umbilical cord blood NK cell therapy for high-risk recurrentrefractory neuroblastoma in children to determine the maximum tolerated dose of umbilical cord blood NK cell therapy in these patients thereby laying the foundation for future combination therapies and phase II and III clinical studies
Detailed Description:
To improve the prognosis of high-risk RecurrentRefractory neuroblastoma we conducted a prospective Phase I clinical trial Patients with high-risk and RecurrentRefractory neuroblastoma who had undergone multidisciplinary treatment received umbilical cord blood NK cell infusions The safety and efficacy of umbilical cord blood NK cells were evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None