Estudio para evaluar la eficacia de Brexucabtagene Autoleucel (KTE-X19) en participantes con linfoma de células del manto en recaída/refractario (cohorte 3) (ZUMA-2)
24 de julio de 2026 actualizado por: Kite, A Gilead Company
Un estudio multicéntrico de fase 2 que evalúa la eficacia de KTE-X19 en sujetos con linfoma de células del manto en recaída/refractario
El objetivo principal es evaluar la eficacia de brexucabtagene autoleucel (KTE-X19) en participantes con linfoma de células del manto (MCL) en recaída/refractario (r/r) en la cohorte 3 de este estudio.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
El estudio KTE-C19-102 (NCT02601313) inscribió a participantes con MCL r/r que habían sido tratados con hasta 5 regímenes previos, incluido un inhibidor de la tirosina quinasa de Bruton (BTKi) en la Cohorte 1 y la Cohorte 2. Sin embargo, para cumplir con el requisito de poscomercialización de la FDA 3 se añade al estudio. Incluirá participantes con MCL r/r que hayan sido tratados con hasta 5 regímenes anteriores pero que no hayan recibido terapia previa con un BTKi.
El análisis primario en la Cohorte 1 y la Cohorte 2 ya está completo. Los datos de la cohorte 3 se analizarán por separado. Por lo tanto, este registro separado es solo para la Cohorte 3.
Después del final de KTE-C19-102, los sujetos que recibieron una infusión de células T CAR anti-CD19 completarán el resto de las evaluaciones de seguimiento de 15 años en un estudio de seguimiento a largo plazo separado, KT-US- 982-5968
Tipo de estudio
Intervencionista
Inscripción (Actual)
95
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Mainz, Alemania, 55101
- Johannes Gutenberg University Hospital-University Mainz
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München, Alemania, 81377
- Munich University of Technology-Medical Faculty- Ethics Committee
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Würzburg, Alemania, 97080
- Universitaetsklinikum Wuerzburg
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Barcelona, España, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, España
- Hospital Clinic Barcelona
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Salamanca, España, 37007
- Hospital Universitario De Salamanca
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Arizona
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Gilbert, Arizona, Estados Unidos, 85234
- Banner MD Anderson Cancer Center
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California
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Palo Alto, California, Estados Unidos, 94305
- Stanford University
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Santa Monica, California, Estados Unidos, 90404
- University California Los Angeles (UCLA)
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Colorado
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Denver, Colorado, Estados Unidos, 80218
- Sarah Cannon- Denver
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami
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Tampa, Florida, Estados Unidos, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Park Ridge, Illinois, Estados Unidos, 60068
- Advocate Aurora Health - Advocate Lutheran General Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Karmanos Cancer Institute
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic - Taussig Cancer Institute
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Columbus, Ohio, Estados Unidos, 43220
- Ohio State University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon - Tenessee
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Baylor Cancer Hospital
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Swedish Cancer Institute
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Montpellier, Francia, 34295
- CHU de Montpellier
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Paris, Francia, 75010
- Hospital Saint Louis
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Pessac, Francia, 44035
- Hôpital Haut-Lévêque
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Pierre-Bénite, Francia, 69495
- Centre Hospitalier LYON SUD
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Rennes, Francia, 35033
- CHU de Rennes
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Amsterdam, Países Bajos, 1100
- Academisch Medisch Centrum
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Groningen, Países Bajos, 9700 RB
- University Medical Center Groningen
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Rotterdam, Países Bajos, 3015 CE
- Erasmus MC
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Glasgow, Reino Unido, G51 4TF
- Queen Elizabeth University Hospital
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London, Reino Unido, SE5 9RS
- Kings College Hospital
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Manchester, Reino Unido, M13 9WL
- Manchester Royal Infirmary
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios clave de inclusión:
- Hasta 5 regímenes previos para LCM. La terapia previa debe haber incluido quimioterapia con antraciclina o bendamustina y terapia con anticuerpos monoclonales anti-CD20. Las personas no deben haber recibido terapia previa con un BTKi.
- Al menos 1 lesión medible
- Recuento de plaquetas ≥ 75.000/ul
- Aclaramiento de creatinina (estimado por Cockcroft Gault) ≥ a 60 cc/min
- Fracción de eyección cardíaca ≥ 50%, sin evidencia de derrame pericárdico según lo determinado por un ecocardiograma (ECHO) o adquisición multigated (MUGA), y sin hallazgos clínicamente significativos en el electrocardiograma (ECG)
- Saturación de oxígeno basal > 92 % en aire ambiente
Criterios clave de exclusión:
- Antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH) o hepatitis B (HBsAG positivo) o virus de la hepatitis C (anti-VHC positivo). Las personas con antecedentes de infección por hepatitis deben haber eliminado su infección según lo determinen las pruebas serológicas y genéticas estándar.
- Antecedentes de un trastorno convulsivo, isquemia/hemorragia cerebrovascular, demencia, enfermedad cerebelosa, edema cerebral, síndrome de encefalopatía posterior reversible o cualquier enfermedad autoinmune con afectación del sistema nervioso central (SNC)
- Presencia de infección fúngica, bacteriana, viral u otra que no esté controlada o que requiera antimicrobianos intravenosos para su manejo
Nota: Es posible que se apliquen otros criterios de inclusión/exclusión definidos en el protocolo.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Brexucabtagene autoleucel (KTE-X19)
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:
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Administered as intravenous infusion
Administered as intravenous infusion
Administered as intravenous infusion
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 3
Periodo de tiempo: Up to 4 years
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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.
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Up to 4 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Porcentaje de participantes con anticuerpos CAR anti-CD19
Periodo de tiempo: Línea de base hasta el mes 3
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Línea de base hasta el mes 3
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Niveles séricos máximos de proteína C reactiva (PCR) en sangre
Periodo de tiempo: Línea de base hasta la semana 4
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El pico se definió como el nivel máximo de citocina posterior al inicio.
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Línea de base hasta la semana 4
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Duration of Response (DOR) Per the Lugano Classification According to IRRC in Cohort 3
Periodo de tiempo: Up to 4 years
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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.
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Up to 4 years
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Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3
Periodo de tiempo: Up to 4 years
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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.
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Up to 4 years
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Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3
Periodo de tiempo: Up to 4 years
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OR was defined in OM #1.
Percentages were rounded-off.
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Up to 4 years
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Progression Free Survival (PFS) Per the Lugano Classification According to IRRC in Cohort 3
Periodo de tiempo: Up to 4 years
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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.
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Up to 4 years
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Overall Survival (OS)
Periodo de tiempo: Up to 4 years
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OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause.
KM estimates were used for analysis.
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Up to 4 years
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: Up to 3 years
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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.
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Up to 3 years
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Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
Periodo de tiempo: Up to 3 years
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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.
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Up to 3 years
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Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
Periodo de tiempo: Up to 3 years
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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.
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Up to 3 years
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Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
Periodo de tiempo: Up to 3 years
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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.
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Up to 3 years
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Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
Periodo de tiempo: Up to 3 years
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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.
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Up to 3 years
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Maximum Number of CAR T Cells Measured Post-infusion
Periodo de tiempo: Up to Month 36
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Up to Month 36
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Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-gamma (IFN-γ), Interleukin (IL)-1 Receptor Antagonist (RA), IL-2, IL-6, IL-7, IL-8, IL-10, IL-15 and Tumor Necrosis Factor (TNF)-α in Blood
Periodo de tiempo: Baseline up to Week 4
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Peak was defined as the maximum post-baseline level of the cytokine.
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Baseline up to Week 4
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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
Periodo de tiempo: Baseline up to Week 4
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Peak was defined as the maximum post-baseline level of the cytokine.
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Baseline up to Week 4
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Percentage of Participants With European Quality of Life-5 Dimensions (EQ-5D) Scale Score at Different Timepoints
Periodo de tiempo: Day 0, Month 18 and Month 24
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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.
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Day 0, Month 18 and Month 24
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EQ-5D Visual Analogue Scale (VAS) Score at Different Timepoints
Periodo de tiempo: Day 0, Month 18 and Month 24
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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.
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Day 0, Month 18 and Month 24
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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
Periodo de tiempo: Screening Day -28 to Leukapheresis (Day -5), Day 0, Month 18 and Month 24
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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.
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Screening Day -28 to Leukapheresis (Day -5), Day 0, Month 18 and Month 24
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Kite Study Director, Kite, A Gilead Company
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Salles 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.
- 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.
- 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.
- Hess 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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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- 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.
- 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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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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- 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.
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- 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.
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Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de abril de 2021
Finalización primaria (Actual)
17 de junio de 2025
Finalización del estudio (Actual)
17 de junio de 2025
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2021
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2021
Publicado por primera vez (Actual)
10 de mayo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Linfoma No Hodgkin
- Linfoma
- Enfermedades hemic y linfáticas
- Linfoma De Células Del Manto
- Químicos orgánicos
- Hidrocarburos
- Mostaza de fosforamida
- Compuestos de mostaza de nitrógeno
- Compuestos de mostaza
- Hidrocarburos, halogenados
- Fosforamidas
- Compuestos organofosforados
- Ciclofosfamida
- fludarabina
- brexucabtagene autoleucel
Otros números de identificación del estudio
- KTE-C19-102 (Cohort 3)
- 2015-005008-27 (Número EudraCT)
- 2023-506641-35 (Otro identificador: European Medicines Agency)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Qualified external researchers may request IPD for this study.
For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
Marco de tiempo para compartir IPD
18 months after study completion and at least 6 months after the FDA and EMA approval
Criterios de acceso compartido de IPD
A secured external environment with username, password, and RSA code.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .