10
Participants
Start Date
October 28, 2021
Primary Completion Date
January 1, 2027
Study Completion Date
January 1, 2027
NEXTGEN-TIL
"NEXTGEN-TIL product is a cellular investigational product comprising a live cell suspension of autologous tumor-infiltrating lymphocytes derived from the patient's own tumor.~Each dose contains at least 5 x 10\^8 total viable lymphocytes, and a maximum of 1.11x10\^11. It will be administered IV on Day 0 (24h after the last dose of Fludarabine)."
Non-myeloablative Lymphodepletion (NMA-LD) Regimen
Patients will receive a NMA-LD chemotherapy based on Cyclophosphamide 60 mg/kg IV (once daily on Days -5 and -4) and Fludarabine 25 mg/m2 IV (once daily on Days -5 to -1).
Interleukin-2
"Patients will receive sequential doses of 720,000 IU/kg IV IL-2 every 8-24 hours depending on patient tolerance. It will be administered on Days 0 to 2, starting between 3 and 24 hours after the completion of NEXTGEN-TIL infusion.~IL-2 doses may be skipped in case of toxicity. If 2 sequential doses or more than 2 non-sequential doses of IL-2 are skipped due to patient intolerance or the discretion of the investigator, IL-2 administration must be stopped."
RECRUITING
Vall d'Hebron Institute of Oncology, Barcelona
Banc de Sang i Teixits
OTHER
Vall d'Hebron Institute of Oncology
OTHER