Study Details

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Relapsed/Refractory Mantle Cell Lymphoma

Gender

N/A

Date

April 2021 - November 2023

Study Type

Interventional

Study Phase

Phase 2

Product

Fludarabine, Cyclophosphamide, Brexucabtagene autoleucel

Eligibility Information

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

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.

Locations

Locations (40)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Stanford University

Palo Alto, California, United States, 94305

University California Los Angeles (UCLA)

Santa Monica, California, United States, 90404

Sarah Cannon- Denver

Denver, Colorado, United States, 80218

University of Miami

Miami, Florida, United States, 33136

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Emory University

Atlanta, Georgia, United States, 30322

University of Chicago

Chicago, Illinois, United States, 60637

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Advocate Aurora Health - Advocate Lutheran General Hospital

Park Ridge, Illinois, United States, 60068

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

University of Rochester

Rochester, New York, United States, 14642

Duke University

Durham, North Carolina, United States, 27710

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, United States, 44195

Ohio State University

Columbus, Ohio, United States, 43220

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Sarah Cannon - Tenessee

Nashville, Tennessee, United States, 37203

Vanderbilt University

Nashville, Tennessee, United States, 37232

Baylor Cancer Hospital

Dallas, Texas, United States, 75246

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Swedish Cancer Institute

Seattle, Washington, United States, 98104

CHU de Montpellier

Montpellier CEDEX 05, France, 34295

Hospital Saint Louis

Paris, France, 75010

Hopital Haut-Leveque

Pessac, France, 44035

Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

CHU de Rennes

Rennes, France, 35033

Johannes Gutenberg University Hospital-University Mainz

Mainz, Germany, 55101

Munich University of Technology-Medical Faculty- Ethics Committee

München, Germany, 81377

Universitaetsklinikum Wuerzburg

Wuerzburg, Germany, 97080

Academisch Medisch Centrum

Amsterdam, Netherlands, 1100

University Medical Center Groningen

Groningen, Netherlands, 9700 RB

Erasmus MC

Rotterdam, Netherlands, 3015 CE

Hospital Universitari Vall D'Hebron

Barcelona, Spain, 08035

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Universitario de Salamanca

Salamanca, Spain, 37007

Queen Elizabeth University Hospital

Glasgow, United Kingdom, G51 4TF

Kings College Hospital

London, United Kingdom, SE5 9RS

Manchester Royal Infirmary

Manchester, United Kingdom, M13 9WL

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

OVERVIEW

PROTOCOL SUMMARY