Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Solid Tumors

"Lymphodepletion regimen：Cyclophosphamide 250mg/ m2/day x 3 days (day -4, -3，-2) , Fludarabine 25mg/ m2/day x 2 days (day-4, -3) , Paclitaxel 100mg/ m2/day -3. The lymphodepletion regimen could be adjusted by the treating physician according to patient's disease condition.~BEN101 infusion： Single dose level between 1x10\^9 to 1x 10\^11，not lower than 1×10\^9 cells, final dose is affected by the starting amount of TILs cells isolated from the tumor tissue sample.~IL-2：Administer 8-16 hr after TIL infusion. 600,000 IU/kg intravenously over 15-20 mins every 12 hours. It is recommended to start with high dose; and de-escalate based on tolerability, up to 5 days. IL-2 administration will be terminated if unacceptable toxicities occur."