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

NCT04880434 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: KTE-C19-102 (Cohort 3)2015-005008-272023-506641-35
• Study Type: interventional
• Target: 95
• Locations: 6 countries
• Sites: 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) who have not previously received Bruton's tyrosine kinase inhibitor (BTKi).

Conditions

Relapsed/Refractory Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 3

  OR: complete metabolic response (CMR),complete radiological response (CRR), partial MR response (PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake ≤mediastinum)/3(uptake \>mediastinum but ≤liver) with/without a residual mass on positron emission tomography 5-point scale;no new lesions.CRR:target nodes/nodal masses regressed to ≤1.5cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal;no new sites;bone marrow normal by morphology. PMR:score 4(uptake moderately \>liver)/5(uptake markedly \>liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment (EOT). PRR: ≥50% decrease in sum of the product of the diameters(SPD) of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs;spleen regressed by \>50% in length beyond normal.

  Up to 4 years

Secondary Outcomes (18)

• Duration of Response (DOR) Per the Lugano Classification According to IRRC in Cohort 3

  Up to 4 years

• Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3

  Up to 4 years

• Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3

  Up to 4 years

• Progression Free Survival (PFS) Per the Lugano Classification According to IRRC in Cohort 3

  Up to 4 years

• Overall Survival (OS)

  Up to 4 years

Study Arms (1)

Brexucabtagene autoleucel (KTE-X19)

EXPERIMENTAL

Participants with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have been treated with up to 5 prior regimens but have not received prior therapy with a Bruton's tyrosine kinase inhibitor (BTKi) will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day for 3 days (Day -5 to Day -3). * A single infusion of brexucabtagene autoleucel at a target dose of 2×10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous 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.

Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Brexucabtagene autoleucel

Interventions

Fludarabine DRUG

Administered as intravenous infusion

Brexucabtagene autoleucel (KTE-X19)

Cyclophosphamide DRUG

Administered as intravenous infusion

Brexucabtagene autoleucel (KTE-X19)

Brexucabtagene autoleucel BIOLOGICAL

Administered as intravenous infusion

Also known as: KTE-X19, Tecartus™

Brexucabtagene autoleucel (KTE-X19)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Up to 5 prior regimens for mantle cell lymphoma (MCL). Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-cluster of differentiation 20 (CD20) monoclonal antibody therapy. Individuals must not have received prior therapy with a Bruton's tyrosine kinase inhibitor (BTKi).
• At least 1 measurable lesion
• Platelet count ≥ 75,000/μL
• 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 anti-hepatitis C virus (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

Sponsors & Collaborators

• Kite, A Gilead Company: lead

Study Sites (40)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

University California Los Angeles (UCLA)

Santa Monica, California, 90404, United States

Location

Sarah Cannon- Denver

Denver, Colorado, 80218, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Advocate Aurora Health - Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43220, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Sarah Cannon - Tenessee

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Baylor Cancer Hospital

Dallas, Texas, 75246, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

CHU de Montpellier

Montpellier, 34295, France

Location

Hospital Saint Louis

Paris, 75010, France

Location

Hopital Haut-Leveque

Pessac, 44035, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Rennes

Rennes, 35033, France

Location

Johannes Gutenberg University Hospital-University Mainz

Mainz, 55101, Germany

Location

Munich University of Technology-Medical Faculty- Ethics Committee

München, 81377, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

Location

Academisch Medisch Centrum

Amsterdam, 1100, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Related Publications (60)

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  PMID: 38494543 BACKGROUND

• Goy A, Jacobson CA, Flinn IW, Hill BT, Weng W, Mountjoy L, et al. Outcomes of patients with relapsed/refractory mantle cell lymphoma (r/r MCL) treated with brexucabtagene autoleucel (brexu-cel) in ZUMA-2 and ZUMA-18, an expanded access study. Blood 2023; 142 (Supplement 1): 106.

  BACKGROUND

• Herbaux C, Bret C, Bachy E, Bories P, Di Blasi R, Cuffel A, Gastinne T, Lamy T, Roussel M, Bouabdallah K, Beauvais D, Cartron G, Bay JO, Blaise D, Rubio MT, Mohty M, Le Bras F, Casasnovas O, Guy J, Guidez S, Llorente CC, Hermine O, La Rochelle LD, Carras S, Guffroy B, Caillat-Zucman S, Houot R, Le Gouill S. Brexucabtagene autoleucel in relapsed or refractory mantle cell lymphoma, intention-to-treat use in the DESCAR-T registry. Haematologica. 2024 Nov 1;109(11):3745-3750. doi: 10.3324/haematol.2023.284786. No abstract available.

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• Kilgore KM, Chan PK, Teigland C, Wade SW, Mohammadi I. Treatment patterns, health care resource utilization, and costs of chimeric antigen receptor T-cell vs standard therapy for relapsed/refractory mantle cell lymphoma in the United States. J Manag Care Spec Pharm. 2025 Mar;31(3):262-276. doi: 10.18553/jmcp.2025.31.3.262.

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• Liebers N, Boumendil A, Finel H, Edelmann D, Kobbe G, Baermann BN, Serroukh Y, Blaise D, Beelen DW, Solano C, Itala-Remes M, van Meerten T, Choi G, Schmidt SAC, Kroger N, Byrne J, Tudesq JJ, Ossami Saidy A, Nunes A, Siddiqi R, Baro E, Zheng D, Kloos I, Dreger P, Sureda A, Glass B, Dietrich S. Brexucabtagene Autoleucel versus Allogeneic Hematopoietic Cell Transplantation in Relapsed and Refractory Mantle Cell Lymphoma. Blood Cancer Discov. 2025 May 5;6(3):182-190. doi: 10.1158/2643-3230.BCD-24-0178.

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• Liebers N, Boumendil A, Finel H, Edelmann D, Kobbe G, Baermann B, et al. A propensity score-matched analysis on outcomes of brexucabtagene autoleucel from ZUMA-2 and allogeneic stem cell transplantation from ebmt database in relapsed/refractory post-btki mantle cell lymphoma. The 50th Annual Meeting of the European Society for Blood and Marrow Transplantation: Physicians Award Winners (O001-O008). Bone Marrow Transplant 2024; 59 (Suppl 1): 12-19; Poster O008.

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• Locke F, Hu ZH, Gerson J, Frank MJ, Budde LE, Wang M, et al. Real-world outcomes of brexucabtagene autoleucel (brexu-cel) for the treatment of relapsed or refractory (r/r) mantle cell lymphoma (mcl) in the United States (US). HemaSphere 2022; 6():1336-1337; Poster 1454.

  BACKGROUND

• Maglinte GA, Simons CL, Wang M, Wade SW, Brown M, Petersohn S, et al. Cost-effectiveness of KTE-X19 CAR-T therapy following bruton tyrosine kinase inhibitor treatment for relapsed/refractory mantle cell lymphoma in England. The 47th Annual Meeting of the European Society for Blood and Marrow Transplantation: Physicians Poster Session (P001-P182. Bone Marrow Transplant 2021;56 (Suppl 1): 184-335; Poster 014.

  BACKGROUND

• Meerten T, Kersten MJ, Iacoboni G, Hess G, Mutsaers P, García-Sancho AM, et al. Primary analysis of ZUMA-2 cohort 3: brexucabtagene autoleucel (brexu-cel) in patients (pts) with relapsed/refractory mantle cell lymphoma (R/R MCL) who were naive to bruton tyrosine kinase inhibitors (BTKi). Blood 2024; 144 (Supplement 1): 748.

  BACKGROUND

• Oluwole OO, Reagan PM, Miklos DB, Locke FL, Goy A, Jacobson CA, et al. Assessment of early intervention strategies for management of cytokine release syndrome and neurologic events after brexucabtagene autoleucel (brexu-cel) treatment in patients with relapsed or refractory mantle cell lymphoma (r/r MCL) in ZUMA-2. Blood 2023; 142 (Supplement 1): 2120.

  BACKGROUND

• Adhikary S, Damico Khalid R, Dreyling M, Galal A, Garcia-Sancho A, Gine E, et al. Two-Year Update of ZUMA-2 Cohort 3: Brexucabtagene Autoleucel (Brexu-Cel) in Patients (Pts) With Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Who Had Not Received Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Therapy [Poster]. American Society of Hematology - 67th Annual Meeting 2025.

  BACKGROUND

• Beitinjaneh A, Chang M, Damico Khalid R, Flinn I, Forcade E, Goy A, et al. Résultats à cinq ans des patients (pts) atteints d'un lymphome à cellules du manteau (LCM) en rechute ou réfractaire (R/R) traités par brexucabtagene autoleucel (brexu-cel) dans les cohortes 1 et 2 (C1&C2) de ZUMA-2 Five-Year Outcomes of Patients (pts) With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL) Treated with Brexucabtagene Autoleucel (brexu-Cel) in ZUMA-2 Cohorts 1 and 2 (c1&c2) [Poster]. Societe Francaise d'Hematologie - 2025 Annual Congress 2025.

  BACKGROUND

• Chen JMH, Zhang I, Wu JJ, et al. Matching-Adjusted Indirect Comparison (MAIC) of Brexucabtagene Autoleucel (Brexu-cel) and Pirtobrutinib in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor (cBTKi) [Poster]. American Society of Hematology - 65th Annual Meeting 2023.

  BACKGROUND

• Chen JMH, Zhang I, Wu JJ, Wade SW, Nunes A, Peng W, et al. Matching-adjusted indirect comparison (maic) of brexucabtagene autoleucel (brexu-cel) and pirtobrutinib in patients with relapsed/refractory (r/r) mantle cell lymphoma (MCL) previously treated with a covalent bruton tyrosine kinase inhibitor (cBTKi). Blood 2023; 142 (Supplement 1): 5136.

  BACKGROUND

• Darnell EP, Gallagher KME, Kanska J, Scarfo I, Balderrama-Gutierrez G, Berger TR, Budka J, Bozym DJ, Huang T, Shen R, Leick MB, Maus MV. Ibrutinib exposure correlates with improved efficacy of CAR T cells in patients with mantle cell lymphoma. Blood Adv. 2026 Feb 24;10(4):1023-1034. doi: 10.1182/bloodadvances.2025018137.

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• Di Blasi R, Hess G, Dreyling M, et al. Overall Survival of Brexucabtagene Autoleucel (Brexu-cel; ZUMA-2) and Standard of Care (SCHOLAR-2) in Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Previously Treated with a Bruton Tyrosine Kinase Inhibitor (BTKi) [Poster]. Societe Francaise d'Hematologie - 2023 Annual Congress 2023.

  BACKGROUND

• Dreyling M, Shah B, Wu J, Chen J, Keeping S, Chan K, et al. Efficacy Outcomes Following Treatment with Bruton Tyrosine Kinase Inhibitors (BTKi) for Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL): A Literature-Based Meta-Analysis [Poster]. International Society for Pharmacoeconomics and Outcomes Research - 27th International Meeting 2022.

  BACKGROUND

• Hess G, Dreyling M, Oberic L, Giné E, Zinzani PL, Linton K, et al. KTE-X19 versus Standard of Care for Relapsed/Refractory Mantle Cell Lymphoma Previously Treated with Bruton Tyrosine Kinase Inhibitors: Real-World Evidence from Europe [Poster]. European Hematology Association - 26th Congress 2021.

  BACKGROUND

• Hess G, Dreyling M, Oberic L, Gine E, Zinzani PL, Linton K, et al. A Comparison of Overall Survival with Brexucabtagene Autoleucel (Brexu-cel) CAR T-Cell Therapy (ZUMA-2) and Standard of Care (SCHOLAR-2) in Patients with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor (BTKi) [Poster]. American Society of Hematology - 64th Annual Meeting 2022.

  BACKGROUND

• Hess G, Dreyling M, Oberic L, et al. A Comparison of Overall Survival with KTE-X19 CAR T-Cell Therapy (ZUMA-2) and Standard-of-Care (SCHOLAR-2) in Patients with Relapsed/Refractory MCL Previously Treated with a Covalent BTKi [Poster]. European Society for Blood and Marrow Transplantation - 49th Annual Meeting 2023.

  BACKGROUND

• Hess G, Dreyling M, Oberic L, Gine E, Zinzani PL, Linton KM, et al. An updated comparison of overall survival with brexucabtagene autoleucel (brexu-cel) CAR T-cell therapy (ZUMA-2) versus standard of care (SCHOLAR-2) in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) previously treated with a covalent bruton tyrosine kinase inhibitor (BTKi). Transplantation and Cellular Therapy 2024; 30(2): S359-S360.

  BACKGROUND

• Kersten MJ, Munoz J, Milpied N, Maglinte GA, Crawford S, Solem CT, et al. Patient Reported Outcomes Among KTE-X19 CAR T Treated Patients with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) [Poster]. International Society for Pharmacoeconomics and Outcomes Research - 23rd Annual European Congress (ISPOR-EU 2020) 2021.

  BACKGROUND

• Kersten, MJ, Munoz, J, Reagan, P, et al. Assessment of durable responses after brexucabtagene autoleucel (KTE X19) in the ZUMA 2 study in relapsed / refractory mantle cell lymphoma (R/R MCL) [Poster]. European CAR T-Cell Meeting - 5th 2023.

  BACKGROUND

• Liebers N, Boumendil A, Finel H, Edelmann D, Kobbe G, Baermann B, et al. A propensity score-matched analysis on the outcomes of brexucabtagene autoleucel from the ZUMA-2 study and allogeneic stem cell transplantation from the ebmt database in relapsed and refractory post-btki mantle cell lymphoma [Oral Presentation]. European Society for Blood and Marrow Transplantation - 50th Annual Meeting 2024.

  BACKGROUND

• Liebers N, Finel H, Edelmann D, Kobbe G, Bärmann B, Serroukh Y, et al. A propensity score matched analysis on the outcomes of brexucabtagene autoleucel from ZUMA 2 study and allogeneic stem cell transplantation from the EBMT database in relapsed and refractory post btki mantle cell lymphoma. Blood 2023; 142 (Supplement 1): 3494.

  BACKGROUND

• Lowin J, Sanderson R, Wastlund D, et al. Life years generated for relapsed/refractory Mantle Cell Lymphoma patients managed on CAR-T in an England NHS setting [Poster]. International Society for Pharmacoeconomics and Outcomes Research - 28th Annual European Congress (ISPOR-EU 2025) 2025.

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• van Meerten T, Kersten MJ, Iacoboni G, Hess G, Mutsaers P, 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. 2026 Mar 19;147(12):1302-1314. doi: 10.1182/blood.2025029734.

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• Munoz J, Reagan P, Goy A, Miklos D, Zheng D, Fang X, et al. Assessment of Durable Responses After Brexucabtagene Autoleucel (KTE-X19) in the ZUMA-2 Study in Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) [Poster]. American Society of Hematology - 64th Annual Meeting 2022.

  BACKGROUND

• Munoz J, Locke FL, Reagan PM, Goy A, Jacobson CA, Hill BT, Timmerman JM, Flinn IW, Miklos DB, Pagel JM, Kersten MJ, Forcade E, Topp MS, Houot R, Beitinjaneh A, Zheng D, Chang M, Zhang W, Shen RR, Khalid RD, Kloos I, Wang ML. Five-year follow-up of patients with relapsed/refractory mantle cell lymphoma treated with anti-CD19 CAR T-cell therapy in ZUMA-2, Cohorts 1 and 2. J Hematol Oncol. 2026 Apr 27;19(1):39. doi: 10.1186/s13045-026-01797-4.

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• Oluwole OO, Reagan PM, Miklos DB, Locke FL, Goy A, Jacobson CA, et al. assessment of early intervention strategies for management of cytokine release syndrome and neurologic events after brexucabtagene autoleucel treatment in patients with relapsed or refractory mantle cell lymphoma in ZUMA-2 [Poster]. American Society of Hematology - 65th Annual Meeting 2023.

  BACKGROUND

• Pindoria L, Munoz J, Reagan P, Goy A, Miklos D, Zheng D, et al. Assessment of Durable Responses After Brexucabtagene Autoleucel (KTE-X19) in the ZUMA-2 Study in Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) [Poster]. British Society for Haematology - 63rd Annual Scientific Meeting 2023.

  BACKGROUND

• Scarfo I, Gallagher KME, Kann M, Leick MB, Budka J, Sowrirajan B, et al. Effects of prior exposure to Tec kinase (BTK/ITK) inhibitors on KTE-X19 products [Poster]. American Society of Hematology - 63rd Annual Meeting 2021.

  BACKGROUND

• Wang M, Locke FL, Siddiqi T, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) [Poster]. European Society for Medical Oncology 41st Congress - ESMO 2016.

  BACKGROUND

• Wang M, Locke FL, Munoz J, Goy A, Holmes HE, Siddiqi T, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) [Poster]. Pan Pacific Lymphoma Conference 2016.

  BACKGROUND

• Wang M, Locke FL, Munoz J, Goy A, Holmes HE, Siddigi T et al. ZUMA 2: Phase 2 Multicenter Study Evaluating Efficacy of KTE C19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma [Poster]. American Society of Clinical Oncology - 54th Annual Meeting 2018.

  BACKGROUND

• Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA, Miklos DB, Pagel JM, Kersten MJ, Milpied N, Fung H, Topp MS, Houot R, Beitinjaneh A, Peng W, Zheng L, Rossi JM, Jain RK, Rao AV, Reagan PM. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2020 Apr 2;382(14):1331-1342. doi: 10.1056/NEJMoa1914347.

  PMID: 32242358 BACKGROUND

• Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Patients (Pts) With Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Results of the Phase 2 ZUMA-2 Study [Poster]. European CAR T-Cell Meeting - 2nd 2020.

  BACKGROUND

• Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Patients (Pts) With Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Results of the Phase 2 ZUMA-2 Study [Poster]. Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR - TCT 2020 2020.

  BACKGROUND

• Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Patients (Pts) With Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Results of the Phase 2 ZUMA-2 Study [Poster]. European Society for Blood and Marrow Transplantation - 46th Annual Meeting 2020.

  BACKGROUND

• Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Patients (Pts) With Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Results of the Phase 2 ZUMA-2 Study [Poster]. Societe Francaise d'Hematologie - 2020 Annual Congress 2020.

  BACKGROUND

• Wang M, Rossi JM, Munoz J,Goy A, Locke FL, Reagan PM, et al. Product Characteristics and Pharmacological Profile of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma in the Phase 2 Registrational ZUMA-2 Trial [Poster]. American Society of Clinical Oncology - 56th Annual Meeting 2020.

  BACKGROUND

• Wang M, Rossi JM, Munoz J, Goy A, Locke FL, Reagan PM, et al. Pharmacological Profile and Clinical Outcomes of KTE-X19 by Prior Bruton Tyrosine Kinase Inhibitor Exposure or Mantle Cell Lymphoma Morphology in Patients With Relapsed/Refractory Mantle Cell Lymphoma in the ZUMA-2 Trial [Poster]. American Society of Hematology - 62nd Annual Meeting 2020.

  BACKGROUND

• Wang ML, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. One-Year Follow-Up of ZUMA-2, the Multicenter, Registrational Study of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma [Poster]. American Society of Hematology - 62nd Annual Meeting 2020.

  BACKGROUND

• Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. KTE-X19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Patients With Relapsed/Refractory Mantle Cell Lymphoma: Results of the Phase 2 ZUMA-2 Study [Poster]. British Society for Haematology - 60th Annual Scientific Meeting 2020.

  BACKGROUND

• Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. One-Year Follow-up of ZUMA-2, the Multicenter, Registrational Study of KTE-X19 in Patients (Pts) with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) [Poster]. Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR - TCT 2021 2021.

  BACKGROUND

• Wang ML, Munoz J, Goy A, et al.. One-Year Follow-Up of ZUMA-2, the Multicenter, Registrational Study of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma [Poster]. European CAR T-Cell Meeting - 3rd 2021.

  BACKGROUND

• Wang M, Rossi JM, Munoz J. Pharmacological Profile and Clinical Outcomes of KTE-X19 by Prior Bruton Tyrosine Kinase Inhibitor Exposure or Mantle Cell Lymphoma Morphology in Patients With Relapsed/Refractory Mantle Cell Lymphoma in the ZUMA-2 Trial [Poster]. European CAR T-Cell Meeting - 3rd 2021.

  BACKGROUND

• Wang ML, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. One-Year Follow-Up of ZUMA-2, the Multicenter, Registrational Study of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma [Poster]. European Society for Blood and Marrow Transplantation - 47th Annual Meeting 2021.

  BACKGROUND

• Wang M, Rossi JM, Munoz J, Goy A, Locke FL, Reagan PM, et al. Pharmacological Profile and Clinical Outcomes of KTE-X19 by Prior Bruton Tyrosine Kinase Inhibitor Exposure or Mantle Cell Lymphoma Morphology in Patients With Relapsed/Refractory Mantle Cell Lymphoma in the ZUMA-2 Trial [Poster]. European Society for Blood and Marrow Transplantation - 47th Annual Meeting 2021.

  BACKGROUND

• Wang M, Rossi JM, Munoz J, Goy A, Locke FL, Reagan PM, et al. Pharmacological Profile and Clinical Outcomes of KTE-X19 By Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Exposure or Mantle Cell Lymphoma (MCL) Morphology in Patients (Pts) with Relapsed/Refractory (R/R) MCL in the ZUMA-2 Trial [Poster]. Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR - TCT 2021.

  BACKGROUND

• Wang ML, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. Outcomes with KTE-X19 in patients (pts) with relapsed/refractory (R/R) mantle cell lymphoma (MCL) in ZUMA-2 who had progression of disease within 24 months of diagnosis (POD24) [Poster]. American Society of Clinical Oncology - 57th Annual Meeting 2021.

  BACKGROUND

• Wang, M, Munoz J, Goy A, Locke F, Jacobson C, et al. Outcomes With KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma in ZUMA-2 Who Had Progression of Disease Within 24 Months of Diagnosis (POD24) [Poster]. European Hematology Association - 26th Congress 2021.

  BACKGROUND

• Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA, Miklos DB, Pagel JM, Kersten MJ, Bouabdallah K, Khanal R, Topp MS, Houot R, Beitinjaneh A, Peng W, Fang X, Shen RR, Siddiqi R, Kloos I, Reagan PM. Three-Year Follow-Up of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma, Including High-Risk Subgroups, in the ZUMA-2 Study. J Clin Oncol. 2023 Jan 20;41(3):555-567. doi: 10.1200/JCO.21.02370. Epub 2022 Jun 4.

  PMID: 35658525 BACKGROUND

• Wang M, Munoz J, Goy A, Locke F, Jacobson C, Hill B, et al. Three-Year Follow-up of Outcomes With KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma in ZUMA-2 [Poster]. European Hematology Association - 27th Congress 2022.

  BACKGROUND

• Wang M, Goy A, Munoz J, Locke FL, Jacobson CA, Hill BT, et al. Five-Year Outcomes of Patients (Pts) With Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Treated With Brexucabtagene Autoleucel (Brexu-cel) in ZUMA-2 Cohorts 1 and 2 [Poster]. American Society of Hematology - 66th Annual Meeting 2024.

  BACKGROUND

• Wang M, Goy A, Munoz J, Locke FL, Jacobson CA, Hill BT, et al. 5-Year Analysis of ZUMA-2 Cohorts 1 and 2: Brexu-Cel in Patients With Relapsed or Refractory MCL [Poster]. American Society of Hematology - 66th Annual Meeting 2024.

  BACKGROUND

• Wang M, Jain P, Chi TL, Chen SE, Heimberger A, Weathers SP, Zheng L, Rao AV, Rossi JM. Management of a patient with mantle cell lymphoma who developed severe neurotoxicity after chimeric antigen receptor T-cell therapy in ZUMA-2. J Immunother Cancer. 2020 Oct;8(2):e001114. doi: 10.1136/jitc-2020-001114.

  PMID: 33067318 BACKGROUND

• Yun K, Sakemura R, Cox M, Huynh T, Manriquez Roman C, Sirpilla O, et al. Immunosuppressive monocyte modulation of CART cell functions could impact response to CART19 in the clinic [Poster]. American Society of Hematology - 64th Annual Meeting 2022.

  BACKGROUND

• Yun K, Sakemura R, Cox M, et al. Differential impact of Monocytes Vs immunosuppressive M2-macrophages on CART19 cell effector functions and outcomes [Poster]. American Association for Cancer Research - 114th Annual Meeting 2023.

  BACKGROUND

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

fludarabine; Cyclophosphamide; brexucabtagene autoleucel

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Medical Information
• Organization: Kite, A Gilead Company

medinfo@kitepharma.com

844-454-5483 (1-844-454-KITE)

Study Officials

• Kite Study Director

  Kite, A Gilead Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 23, 2021
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: August 18, 2026
• Results First Posted: August 18, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion and at least 6 months after the FDA and EMA approval
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

NL (3); GB (3); FR (5); US (23); ES (3); DE (3)