70
Participants
Start Date
February 28, 2023
Primary Completion Date
November 30, 2025
Study Completion Date
November 30, 2027
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.
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.
CISH Inactivated 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.
Pembrolizumab
Administered as maintenance therapy in some patients starting at first follow-up (400 mg/dose starting Day 28 /Week 4 then every 6 weeks thereafter until disease progression, unacceptable toxicity, or up to 24 months)
Masonic Cancer Center, University of Minnesota, Minneapolis
City of Hope Comprehensive Cancer Center, Duarte
Lead Sponsor
Intima Bioscience, Inc.
INDUSTRY