Evaluate the Safety of UF-KURE19 Cells in Non-Hodgkin Lymphomas

PHASE1RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

April 26, 2023

Primary Completion Date

October 1, 2025

Study Completion Date

April 1, 2026

Conditions
Non Hodgkin Lymphoma
Interventions
BIOLOGICAL

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

DRUG

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.

DRUG

Cyclophosphamide

The mechanism of action is thought to involve cross-linking of tumor cell DNA

Trial Locations (3)

44106

RECRUITING

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland

44195

RECRUITING

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland

52242

SUSPENDED

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

All Listed Sponsors
lead

David Wald

OTHER