40
Participants
Start Date
January 15, 2025
Primary Completion Date
September 30, 2029
Study Completion Date
September 30, 2029
NMA-LD regimen
The use of the NMA-LD regimen (cyclophosphamide and fludarabine) prior to cell administration is expected to lead to myelosuppression in all patients.
Tumor infiltrating lymphocytes adoptive cell therapy (TIL-ACT) infusion
On Day 0 (at least 24h after the last dose of fludarabine) patients will be hospitalized in a dedicated unit. Autologous TIL infusion will be administered intravenously.
High dose IL-2
"Only for patients in Arm A.~IL-2 begins between 3 and 24 hours after the completion of the TIL infusion and is given as a bolus administration every eight hours (minimum interval) to 24 hours (maximum interval) with a maximum of six doses from the beginning of each administration."
IL-2 analog
"Only for patients in Arm B~ANV419 will be administered between 3 and 24 hours after the completion of the TIL infusion with a slow IV infusion over 15-30 minutes + 5 minutes once, at 243µg/kg."
RECRUITING
Vall d'Hebron Institute of Oncology, Barcelona
Banc de Sang i Teixits
OTHER
Vall d'Hebron Institute of Oncology
OTHER