20
Participants
Start Date
May 15, 2020
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
Cyclophosphamide
Day -6 and Day -5: Cyclophosphamide 60 mg/kg/dose as a 2 hour intravenous infusion with Mesna 15 mg/kg/dose, 1st dose prior to Cyclophosphamide infusion then at 3,6,9 and 12 hours later.
Fludarabine
Day -7 to Day -3 : Fludarabine 25 mg/m\^2/dose as a 1 hour intravenous infusion per institutional guidelines once a day for 5 doses beginning on Day -7. Fludarabine will be started approximately 1 to 2 hours after the cyclophosphamide on Day -6 and Day -5.
Tumor-Infiltrating Lymphocytes (TIL)
Day 0 : Each bag of autologous CISH inactivated TIL for infusion will be administered intravenously (IV) on the Patient Care Unit over 10-20 minutes at assigned dose level.
Aldesleukin
Days 1-4 : Aldesleukin at 720,000 U/kg as an intravenous infusion, every 8 -12 hours but, no more than 24 hours apart as tolerated for up to 6 doses.
Masonic Cancer Center, University of Minnesota, Minneapolis
Lead Sponsor
Masonic Cancer Center, University of Minnesota
OTHER
Intima Bioscience, Inc.
INDUSTRY