17
Participants
Start Date
November 22, 2022
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
TBio-4101
TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product that involves the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell.
Cyclophosphamide
Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL over approximately 1 hour per day for 2 days.
Fludarabine
Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 15 to 30 minutes for 5 days, prior to T-Cell infusion
Interleukin-2
Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously every 8 to 12 hours beginning within 24 hours after T-cell infusion.
Moffitt Cancer Center, Tampa
Turnstone Biologics, Corp.
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER