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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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.
interventionNames
Drug: Fludarabine
Drug: Cyclophosphamide
Biological: Brexucabtagene autoleucel
Primary outcomes (1)
measure
Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 3
timeFrame
Up to 4 years
description
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.
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
Key Inclusion Criteria:
* 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
Key Exclusion Criteria:
* 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (60)
BACKGROUNDSalles G, Chen JMH, Zhang I, Kerbauy F, Wu JJ, Wade SW, Nunes A, Feng C, Kloos I, Peng W, Snider JT, Maciel D, Chan K, Keeping S, Shah B. Matching-Adjusted Indirect Comparison of Brexucabtagene Autoleucel (ZUMA-2) and Pirtobrutinib (BRUIN) in Patients with Relapsed/Refractory Mantle Cell Lymphoma Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor. Adv Ther. 2024 May;41(5):1938-1952. doi: 10.1007/s12325-024-02822-z. Epub 2024 Mar 18. PMID 38494543
BACKGROUNDGoy 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.
BACKGROUNDHerbaux 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. PMID 38899352
BACKGROUNDHess G, Dreyling M, Oberic L, Gine E, Zinzani PL, Linton K, Vilmar A, Jerkeman M, Chen JMH, Ohler A, Stilgenbauer S, Thieblemont C, Lambert J, Zilioli VR, Sancho JM, Jimenez-Ubieto A, Fischer L, Eyre TA, Keeping S, Park JE, Wu JJ, Nunes A, Reitan J, Wade SW, Salles G. Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma. Leuk Lymphoma. 2024 Jan;65(1):14-25. doi: 10.1080/10428194.2023.2268228. Epub 2024 Jan 10. PMID 37840282
BACKGROUNDKilgore 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.
Secondary outcomes (18)
measure
Duration of Response (DOR) Per the Lugano Classification According to IRRC in Cohort 3
timeFrame
Up to 4 years
description
DOR: time from the first OR to progressive disease (PD)/death. It was determined using Kaplan-Meier (KM) estimates. PD: score 4 (uptake moderately \> liver)/ 5 (uptake markedly \>liver and/or new lesions) with an increase in intensity of uptake from baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi \> 1.5 cm, increase by ≥ 50% from cross-product of LDi and perpendicular diameter (PPD) nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by \> 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the increase must be ≥ 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement.
measure
Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3
timeFrame
Up to 4 years
description
BOR consisted of complete response (CR), partial response (PR), stable disease (SD), PD, not done and not evaluable (NE). CR=CMR/CRR and PR=PMR/PRR were defined in Outcome Measure (OM) 1. SD/no metabolic response (NMR): a score 4 (uptake moderately greater than (\>) liver) or 5 (uptake markedly \>liver and/ or new lesions) with no significant change in FDG uptake compared to baseline (screening), at an interim time point or end of treatment; no new sites of disease should be observed. PD was defined in OM 2. Not done: no assessment at the time of analysis. Clopper-Pearson method was used for OM analysis. Percentages were rounded off.
measure
Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3
timeFrame
Up to 4 years
description
OR was defined in OM #1. Percentages were rounded-off.
measure
Progression Free Survival (PFS) Per the Lugano Classification According to IRRC in Cohort 3
timeFrame
Up to 4 years
description
PFS was defined as the time from brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD was defined in OM #2. Kaplan-Meier (KM) estimates were used for analysis.
measure
Overall Survival (OS)
timeFrame
Up to 4 years
description
OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. KM estimates were used for analysis.
measure
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
timeFrame
Up to 3 years
description
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participants. The event did not necessarily have a relationship with study treatment. AE included worsening of a pre-existing medical condition. Worsening indicated that the pre-existing medical condition had increased in severity, frequency, and/or duration or had an association with a worse outcome. A pre-existing condition that had not worsened during the study or involved an intervention such as elective cosmetic surgery or a medical procedure while on study, was not considered an AE. TEAE was defined as any AE with onset on or after the start of treatment.
measure
Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
timeFrame
Up to 3 years
description
Laboratory results were graded according to National Cancer Institute Common Terminology Criteria for Adverse Event (CTCAE) version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
measure
Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
timeFrame
Up to 3 years
description
Laboratory results were graded according to National Cancer Institute CTCAE version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
measure
Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
timeFrame
Up to 3 years
description
Laboratory results were graded according to National Cancer Institute CTCAE version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
measure
Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
timeFrame
Up to 3 years
description
Laboratory results were graded according to National Cancer Institute CTCAE version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
measure
Percentage of Participants With Anti-CD19 CAR Antibodies
timeFrame
Baseline up to Month 3
measure
Maximum Number of CAR T Cells Measured Post-infusion
timeFrame
Up to Month 36
measure
Peak Serum Levels of C-Reactive Protein (CRP) in Blood
timeFrame
Baseline up to Week 4
description
Peak was defined as the maximum post-baseline level of the cytokine.
Peak was defined as the maximum post-baseline level of the cytokine.
measure
Peak Serum Levels of Ferritin, Intercellular Adhesion Molecule (ICAM)-1, IL-2 Receptor Alpha (Rα), Perforin and Vascular Cell Adhesion Molecule (VCAM)-1 in Blood
timeFrame
Baseline up to Week 4
description
Peak was defined as the maximum post-baseline level of the cytokine.
measure
Percentage of Participants With European Quality of Life-5 Dimensions (EQ-5D) Scale Score at Different Timepoints
timeFrame
Day 0, Month 18 and Month 24
description
The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) was a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant was asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, were converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. Percentage of participants with each scale score for all 5 dimensions are reported. Percentages were rounded-off.
measure
EQ-5D Visual Analogue Scale (VAS) Score at Different Timepoints
timeFrame
Day 0, Month 18 and Month 24
description
EQ-5D was a standardized participant completed questionnaire that measures health-related quality of life and translated the score into an index value or utility score. EQ-5D-consisted of two components: a health state profile and an optional visual analogue scale (VAS). The EQ-5D-VAS recorded the participant's self-rated health on a vertical visual analogue scale, where the endpoints were labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicated better self-reported health status.
measure
Percentage of Participants With Deterioration Scores From Screening in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
timeFrame
Screening Day -28 to Leukapheresis (Day -5), Day 0, Month 18 and Month 24
description
EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status/quality of life (QoL) scale, symptom scales (fatigue, pain, nausea/vomiting), and single items scales (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores are averaged, transformed to 0-100 scale. Higher scores for functional scales and for the global health status/QoL scale indicate a higher level of functioning and a better health-related QoL, whereas higher scores in symptom scales represent a higher level of symptoms. Deterioration of score was defined as worsened by at least 1 level from screening. Participants with answer "Yes" to the EORTC functional scale questionnaire were reported.
BACKGROUNDLiebers 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. PMID 39913291
BACKGROUNDLiebers 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.
BACKGROUNDLocke 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.
BACKGROUNDMaglinte 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.
BACKGROUNDMeerten 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.
BACKGROUNDOluwole 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.
BACKGROUNDAdhikary 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.
BACKGROUNDBeitinjaneh 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.
BACKGROUNDChen 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.
BACKGROUNDChen 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.
BACKGROUNDDarnell 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. PMID 41686452
BACKGROUNDDi 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.
BACKGROUNDDreyling 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.
BACKGROUNDHess 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.
BACKGROUNDHess 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.
BACKGROUNDHess 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.
BACKGROUNDHess 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.
BACKGROUNDKersten 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.
BACKGROUNDKersten, 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.
BACKGROUNDLiebers 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.
BACKGROUNDLiebers 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.
BACKGROUNDLowin 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.
BACKGROUNDvan 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. PMID 41160777
BACKGROUNDMunoz 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.
BACKGROUNDMunoz 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. PMID 42036693
BACKGROUNDOluwole 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.
BACKGROUNDPindoria 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.
BACKGROUNDScarfo 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang, 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.
BACKGROUNDWang 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
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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.
BACKGROUNDWang 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
BACKGROUNDYun 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.
BACKGROUNDYun 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.