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COMPLETED
NCT04880434
PHASE2

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)

Sponsor: Kite, A Gilead Company

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL) who have not previously received Bruton's tyrosine kinase inhibitor (BTKi).

Official title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

95

Start Date

2021-04-23

Completion Date

2025-06-17

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DRUG

Fludarabine

Administered as intravenous infusion

DRUG

Cyclophosphamide

Administered as intravenous infusion

BIOLOGICAL

Brexucabtagene autoleucel

Administered as intravenous infusion

Locations (40)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Stanford University

Palo Alto, California, United States

University California Los Angeles (UCLA)

Santa Monica, California, United States

Sarah Cannon- Denver

Denver, Colorado, United States

University of Miami

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Advocate Aurora Health - Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

University of Rochester

Rochester, New York, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Sarah Cannon - Tenessee

Nashville, Tennessee, United States

Vanderbilt University

Nashville, Tennessee, United States

Baylor Cancer Hospital

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

CHU de Montpellier

Montpellier, France

Hospital Saint Louis

Paris, France

Hopital Haut-Leveque

Pessac, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CHU de Rennes

Rennes, France

Johannes Gutenberg University Hospital-University Mainz

Mainz, Germany

Munich University of Technology-Medical Faculty- Ethics Committee

München, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Academisch Medisch Centrum

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Erasmus MC

Rotterdam, Netherlands

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Kings College Hospital

London, United Kingdom

Manchester Royal Infirmary

Manchester, United Kingdom