UF-KURE19 CAR-T cells for Non-Hodgkin's Lymphoma (NHL)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, OH
Non-Hodgkin's Lymphoma (NHL)+2 More
UF-KURE19 CAR-T cells - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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 The CAR-T cells that will be reinfused into the body are modified using a lentivirus that is no longer active.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.

Eligible Conditions

  • Non-Hodgkin's Lymphoma (NHL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Non-Hodgkin's Lymphoma (NHL)

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 2 weeks after culture of UF-KURE19 CAR-T cells

Week 2
Rate of UF-KURE19 CAR-T cells manufacture success
Month 12
Incidence of treatment- emergent AEs (TEAEs)
Overall Response
Progression-free survival (PFS)
Toxicities associated with the MTD of UF-KURE19 CAR-T Cells
Year 15
Overall Survival
Day 28
Recommend MTD dose of UF-KURE19 CAR-T Cells

Trial Safety

Safety Progress

1 of 3

Other trials for Non-Hodgkin's Lymphoma (NHL)

Trial Design

1 Treatment Group

UF-KURE19 CAR-T cell infusion
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: UF-KURE19 CAR-T cells · No Placebo Group · Phase 1

UF-KURE19 CAR-T cell infusionExperimental Group · 3 Interventions: UF-KURE19 CAR-T cells, Cyclophosphamide, Fludarabine · Intervention Types: Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~4020
Fludarabine
2012
Completed Phase 2
~1240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks after culture of uf-kure19 car-t cells
Closest Location: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center · Cleveland, OH
Photo of Cleveland 1Photo of Cleveland 2Photo of Cleveland 3
2004First Recorded Clinical Trial
3 TrialsResearching Non-Hodgkin's Lymphoma (NHL)
103 CompletedClinical Trials

Who is running the clinical trial?

James Michael MartinLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a male or female aged 18 years or older.
At least one measurable lesion according to Lugano Revised Response Criteria for Malignant Lymphoma.
You have received radiation therapy or systemic therapy to treat malignancy at the time of leukapheresis.
You have total bilirubin that is below the institutional upper limit of normal.
AST/ALT ratio > 2.5 X institutional upper limit of normal.
You have a calculated creatinine clearance of 30mL/min or greater.
You have adequate pulmonary function, defined as ≤ Grade 1 dyspnea (unless considered secondary to lymphoma) and oxygen saturation (SaO2) ≥ 92% on room air.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.