Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)
ZUMA-2
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
2 other identifiers
interventional
95
6 countries
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2021
Typical duration for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 27, 2021
CompletedFirst Submitted
Initial submission to the registry
April 30, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2025
CompletedNovember 17, 2025
November 1, 2025
4.1 years
April 30, 2021
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) Per Lugano Classification as Determined by the Independent Radiology Review Committee (IRRC)
ORR is defined as the incidence of either a complete response (CR) or partial response (PR) per the Lugano Classification as determined by IRRC.
Up to 4 years
Secondary Outcomes (13)
Duration of Response (DOR)
Up to 4 years
Percentage of Participants With Best Objective Response (BOR)
Up to 4 years
Objective Response Rate (ORR) per Lugano Classification as Determined by Investigators
Up to 4 years
Progression Free Survival (PFS)
Up to 4 years
Overall Survival
Up to 4 years
- +8 more secondary outcomes
Study Arms (1)
Brexucabtagene autoleucel (KTE-X19)
EXPERIMENTALParticipants 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.
Interventions
A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Stanford University
Palo Alto, California, 94305, United States
University California Los Angeles (UCLA)
Santa Monica, California, 90404, United States
Sarah Cannon- Denver
Denver, Colorado, 80218, United States
University of Miami
Miami, Florida, 33136, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Advocate Aurora Health - Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of Rochester
Rochester, New York, 14642, United States
Duke University
Durham, North Carolina, 27710, United States
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43220, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Sarah Cannon - Tenessee
Nashville, Tennessee, 37203, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Baylor Cancer Hospital
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
CHU de Montpellier
Montpellier, 34295, France
Hospital Saint Louis
Paris, 75010, France
Hopital Haut-Leveque
Pessac, 44035, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU de Rennes
Rennes, 35033, France
Johannes Gutenberg University Hospital-University Mainz
Mainz, 55101, Germany
Munich University of Technology-Medical Faculty- Ethics Committee
München, 81377, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080, Germany
Academisch Medisch Centrum
Amsterdam, 1100, Netherlands
University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Erasmus MC
Rotterdam, 3015 CE, Netherlands
Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Related Publications (1)
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.
PMID: 41160777DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kite Study Director
Kite, A Gilead Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2021
First Posted
May 10, 2021
Study Start
April 27, 2021
Primary Completion
June 17, 2025
Study Completion
June 17, 2025
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share