NCT05400109

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

A Phase 1/1b Multicenter, Open Label Study to Evaluate the Safety of UF-KURE19 Cells in Patients With B Cell Non-Hodgkin Lymphomas

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: David Wald · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to determine the safety and efficacy of the infusion of autologous CD19 CAR-T cells that are manufactured using an ultra-fast process.

Detailed description

This treatment uses T cells already present in the participant's body that have been modified outside of the body by a lentivirus and then returned by an infusion to target the cancer. Lentivirus is a family of viruses that can be used by scientists to alter cells. The specific type of cells that will be used is called UF-KURE19 chimeric antigen receptor T cells (CAR-T cells). The CAR-T cells that will be reinfused into the body are modified using a lentivirus that is no longer active. The investigators are evaluating UF-KURE19 because it uses a process that is shorter than other approved CAR-T cells. While the shorter manufacture time can be an advantage, the safety of this approach has not been demonstrated.

Conditions

• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-26
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2022-06-01
• Last updated: 2026-01-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study