33
Participants
Start Date
March 8, 2022
Primary Completion Date
July 16, 2025
Study Completion Date
July 16, 2025
IL-2 (Aldesleukin)
dose of 720,000 IU/kg (based on total body weight) as an intravenous bolus over a 15 minute period beginning within 24 hours of cell infusion and continuing for up to four days (maximum 12 doses).
Cyclophosphamide
30 mg/kg IV infusion over 1 hour (+ 10 min) Once daily x 2 doses (Days -6 and -5)
KK-LC-1 TCR
1 x 108 transduced KK-LC-1 TCR T cells
Fludarabine
25 mg/m2 IV infusion over 30 minutes (+ 10 min) To be administered following completion of cyclophosphamide. Once daily x 5 doses (Days -6, -5, -4, -3, -2)
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH