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

NCT ID: NCT04880434

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2025-06-17

Brief 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).

Detailed Description

Study KTE-C19-102 (NCT02601313) enrolled participants with r/r MCL who have been treated with up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and Cohort 2. However, to fulfill FDA Postmarketing Requirement Cohort 3 is added to the study. It will include participants with r/r MCL who have been treated with up to 5 prior regimens but have not received prior therapy with a BTKi.

The primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3 will be analyzed separately. Therefore, this separate registration is only for Cohort 3.

After the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Conditions

Relapsed/Refractory Mantle Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brexucabtagene autoleucel (KTE-X19)

Participants with relapsed/refractory mantle cell lymphoma will receive conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day intravenous (IV) infusion for 3 days followed by a single infusion of brexucabtagene autoleucel (KTE-X19) at a targeted dose of 2 x 10\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg, with a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0 in Cohort 3.

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

Administered intravenously

Cyclophosphamide

Intervention Type: DRUG

Administered intravenously

Brexucabtagene autoleucel

Intervention Type: BIOLOGICAL

A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells

Interventions

Fludarabine

Administered intravenously

Intervention Type: DRUG

Cyclophosphamide

Administered intravenously

Intervention Type: DRUG

Brexucabtagene autoleucel

A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells

Intervention Type: BIOLOGICAL

Other Intervention Names

KTE-X19; TECARTUS™

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kite, A Gilead Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kite Study Director

Role: STUDY_DIRECTOR

Kite, A Gilead Company

Locations

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

Countries

United States; France; Germany; Netherlands; Spain; United Kingdom

References

van Meerten T, Kersten MJ, Iacoboni G, Hess GR, Mutsaers PGNJ, Martin Garcia-Sancho AM, Goy A, Gine E, Hill BT, Weng WK, Reagan PM, Patel K, Galal A, Herbaux C, Sanderson R, Forcade E, Topp MS, Houot R, Zheng D, Zhang W, Kanska J, Shen RR, Damico Khalid R, Kloos I, Dreyling M, Wang ML. Brexucabtagene autoleucel for BTKi-naive relapsed/refractory mantle cell lymphoma: primary analysis of ZUMA-2 Cohort 3. Blood. 2025 Oct 29:blood.2025029734. doi: 10.1182/blood.2025029734. Online ahead of print.

Reference Type: DERIVED

PMID: 41160777 (View on PubMed)

Related Links

https://www.gileadclinicaltrials.com/study/?id=KTE-C19-102%20(Cohort%203)

Gilead Clinical Trials Website

Other Identifiers

2015-005008-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KTE-C19-102 (Cohort 3)

Identifier Type: -

Identifier Source: org_study_id