The content of this website is intended for United States audiences only.

Report an Adverse Event
/-/media/project/gileadclinicaltrial/header/arrow-right-img.svg
Back Arrow Back to search results
Global Share

STATUS Recruitment Complete

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) (ZUMA-2)

LAST UPDATED

March 25 2025

Clinicaltrials.gov ID

NCT04880434

EudraCT ID

2015-005008-27

OVERVIEW

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

PROTOCOL 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).

View More

Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Relapsed/Refractory Mantle Cell Lymphoma

Gender

N/A

Date

April 2021 - November 2024

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Fludarabine, Cyclophosphamide, Brexucabtagene autoleucel

Eligibility Information

Inclusion

Inclusion Criteria

  • Up to 5 prior regimens for MCL. Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy. Individuals must not have received prior therapy with a BTKi.
  • At least 1 measurable lesion
  • Platelet count ≥ 75,000/uL
  • Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/min
  • Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA), and no clinically significant electrocardiogram (ECG) findings
  • Baseline oxygen saturation > 92% on room air
VIEW MORE
Exclusion

Exclusion Criteria

  • Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing
  • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
VIEW MORE

Locations

Locations (40)
Other

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Other

Stanford University

Palo Alto, California, United States, 94305

Other

University California Los Angeles (UCLA)

Santa Monica, California, United States, 90404

Other

Sarah Cannon- Denver

Denver, Colorado, United States, 80218

Other

University of Miami

Miami, Florida, United States, 33136

Other

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Other

Emory University

Atlanta, Georgia, United States, 30322

Other

University of Chicago

Chicago, Illinois, United States, 60637

Other

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Other

Advocate Aurora Health - Advocate Lutheran General Hospital

Park Ridge, Illinois, United States, 60068

Other

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Other

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Other

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Other

University of Rochester

Rochester, New York, United States, 14642

Other

Duke University

Durham, North Carolina, United States, 27710

Other

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, United States, 44195

Other

Ohio State University

Columbus, Ohio, United States, 43220

Other

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Other

Sarah Cannon - Tenessee

Nashville, Tennessee, United States, 37203

Other

Vanderbilt University

Nashville, Tennessee, United States, 37232

Other

Baylor Cancer Hospital

Dallas, Texas, United States, 75246

Other

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Other

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Other

CHU de Montpellier

Montpellier CEDEX 05, France, 34295

Other

Hospital Saint Louis

Paris, France, 75010

Other

Hopital Haut-Leveque

Pessac, France, 44035

Other

Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

Other

CHU de Rennes

Rennes, France, 35033

Other

Johannes Gutenberg University Hospital-University Mainz

Mainz, Germany, 55101

Other

Munich University of Technology-Medical Faculty- Ethics Committee

München, Germany, 81377

Other

Universitaetsklinikum Wuerzburg

Wuerzburg, Germany, 97080

Other

Academisch Medisch Centrum

Amsterdam, Netherlands, 1100

Other

University Medical Center Groningen

Groningen, Netherlands, 9700 RB

Other

Erasmus MC

Rotterdam, Netherlands, 3015 CE

Other

Hospital Universitari Vall D'Hebron

Barcelona, Spain, 08035

Other

Hospital Clinic Barcelona

Barcelona, Spain

Other

Hospital Universitario de Salamanca

Salamanca, Spain, 37007

Other

Queen Elizabeth University Hospital

Glasgow, United Kingdom, G51 4TF

Other

Kings College Hospital

London, United Kingdom, SE5 9RS

Other

Manchester Royal Infirmary

Manchester, United Kingdom, M13 9WL