Feasibility clinical trial of the sequential combination of AloCelyvir and activated tumor-infiltrating lymphocytes (TILs) for the treatment of children and young adults with advanced neuroblastoma

Condition studied

High-risk relapsed/refractory (R/R) neuroblastoma (NB).

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary endpoint is Dose-Limiting Toxicity (DLT) of the sequential combination of AloCelyvir plus TILs.

Endpoint detail

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.