25
Participants
Start Date
January 14, 2019
Primary Completion Date
October 16, 2024
Study Completion Date
August 18, 2039
CAR138 T Cells
"The MTD is defined as the dose at which approximately 0.20 of subjects experience DLT dose escalation guided by the continual reassessment method (CRM).~Six dose levels will be evaluated:~Dose level 1: 5X10\^6 cells/m\^2 Dose level 2: 1X10\^7 cells/m\^2 Dose level 3: 2.5X10\^7 cells/m\^2 Dose level 4: 5X10\^7 cells/m\^2 Dose level 5: 1x10\^8 cells/m\^2 Dose level 6: 2x10\^8 cells/m\^2~Six subjects will be enrolled at the MTD to better characterize safety at that dose level.~Cell Administration: CAR138 T cells will be given by intravenous injection over through either a peripheral or a central line.~The lymphodepletion regimen will consist of intravenous cyclophosphamide 300 mg/m\^2 and fludarabine 30 mg/m\^2 given once daily for three days."
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Baylor College of Medicine
OTHER
UNC Lineberger Comprehensive Cancer Center
OTHER