70
Participants
Start Date
May 16, 2019
Primary Completion Date
December 1, 2027
Study Completion Date
December 1, 2028
Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Fludarabine
Days -7 to -3: Fludarabine 25 mg/m\^2/day IVPB daily over 30 minutes for 5 days.
Aldesleukin
Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 3 days (maximum 9 doses).
anti-KRAS G12D mTCR PBL
Day 0: Cells will be infused intravenously on the Patient Care Unit over 20-30 minutes (2-4 days after the last dose of fludarabine).
RECRUITING
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH