High-risk relapsed/refractory (R/R) neuroblastoma (NB).
Conditions
Brief summary
The primary endpoint is Dose-Limiting Toxicity (DLT) of the sequential combination of AloCelyvir plus TILs.
Detailed description
Nature and frequency of adverse events (AEs), serious adverse events (SAEs), abnormalities in laboratory test results, vital sign measurements, and physical examination findings, graded, when applicable, according to NCI-CTCAE version 5.0., Response rate (complete and partial)., Clinical benefit rate (complete response, partial response, minor response, and stable disease)., Time from enrollment to preparation and administration of AloCelyvir., Time from enrollment to preparation and administration of TILs., Progression-free survival., Overall survival.
Interventions
DRUGAutologous tumor-infiltrating T lymphocytes
DRUGex vivo expanded with interleukin-7
DRUGinterleukin-15 and interleukin-21
DRUGAloCelyvir
Sponsors
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is Dose-Limiting Toxicity (DLT) of the sequential combination of AloCelyvir plus TILs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Nature and frequency of adverse events (AEs), serious adverse events (SAEs), abnormalities in laboratory test results, vital sign measurements, and physical examination findings, graded, when applicable, according to NCI-CTCAE version 5.0., Response rate (complete and partial)., Clinical benefit rate (complete response, partial response, minor response, and stable disease)., Time from enrollment to preparation and administration of AloCelyvir., Time from enrollment to preparation and administration of TILs., Progression-free survival., Overall survival. | — |
Outcome results
None listed