46
Participants
Start Date
April 26, 2023
Primary Completion Date
October 1, 2025
Study Completion Date
April 1, 2026
UF-KURE19 CAR-T cells
UF-KURE19 cells are initially generated from a starting autologous apheresis sample. T cells are activated and transduced with Kure19 lentiviral vector that consists of a 3rd generation vector with an scFV (FMC63) that targets CD19. The product is harvested at 17-20hr after culture and cryopreserved
Fludarabine
Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis.
Cyclophosphamide
The mechanism of action is thought to involve cross-linking of tumor cell DNA
RECRUITING
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland
RECRUITING
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland
SUSPENDED
University of Iowa/Holden Comprehensive Cancer Center, Iowa City
David Wald
OTHER