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

NCT05400109 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-05-05

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • David Wald

    lead OTHER

Principal Investigators

  • Changchun Deng, MD, PhD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2026-10-01
Completion
2026-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05400109 on ClinicalTrials.gov