3
Participants
Start Date
April 1, 2022
Primary Completion Date
December 30, 2027
Study Completion Date
December 30, 2027
CYCLOPHOSPHAMIDE and FLUDARABIN
1\. CYCLOPHOSPHAMIDE 250 mg/msq, Day -5,-4,-3 with FLUDARABIN 25 mg/msq, Day -5,-4,-3
Cyclophosphamide
CYCLOPHOSPHAMIDE 250 mg/msq, Day -6, -5,-4,-3
HBI 0201-ESO TCRT
HBI 0201-ESO TCRT will be infused on Day 0, after lymphodepletion. Three dose levels will be evaluated: 1x10E9, 5x10E9 and 1x10E10.
Aldesleukin
Continuous infusion of aldesleukin 18x10E6 IU/24h will be given 24 hours post HBI 0201-ESO TCRT infusion, for four days or until a dose limiting toxicity will occur that mimics cytokine release syndrome (CRS) including blood pressure drop, oliguria or confusion- all of them or any one alone.
RECRUITING
Hadassah Medical Organization, Jerusalem
Hadassah Medical Organization
OTHER