Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 5:28 PM
Study NCT ID:
NCT04880434
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C000705347', 'term': 'brexucabtagene autoleucel'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Per Lugano Classification as Determined by the Independent Radiology Review Committee (IRRC)', 'timeFrame': 'Up to 4 years', 'description': 'ORR is defined as the incidence of either a complete response (CR) or partial response (PR) per the Lugano Classification as determined by IRRC.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 4 years', 'description': 'DOR is defined as the time from their first objective response to disease progression or death.'}, {'measure': 'Percentage of Participants With Best Objective Response (BOR)', 'timeFrame': 'Up to 4 years', 'description': 'Best objective response is defined as the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable as best response to treatment.'}, {'measure': 'Objective Response Rate (ORR) per Lugano Classification as Determined by Investigators', 'timeFrame': 'Up to 4 years', 'description': 'ORR, as determined by investigators, is defined as the incidence of either a complete response (CR) or partial response (PR) per the Lugano Classification.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 4 years'}, {'measure': 'Percentage of Participants Experiencing Treatment-Emergent Adverse Events', 'timeFrame': 'Up to 4 years'}, {'measure': 'Percentage of Participants With Clinically Significant Changes in Laboratory Values', 'timeFrame': 'Up to 4 years'}, {'measure': 'Percentage of Participants Who Develop Anti-CD19 CAR Antibodies', 'timeFrame': 'Up to 4 years'}, {'measure': 'Levels of Anti-CD19 CAR T Cells in Blood', 'timeFrame': 'Up to 4 years'}, {'measure': 'Levels of Cytokines in Serum', 'timeFrame': 'Up to 4 years'}, {'measure': 'Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Scale Score', 'timeFrame': 'Baseline and up to 24 months', 'description': 'The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is 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, are 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. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline.'}, {'measure': 'Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Visual Analogue Scale (VAS) Score', 'timeFrame': 'Baseline and up to 24 months', 'description': "EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status."}, {'measure': 'Changes in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score from Baseline Over Time', 'timeFrame': 'Baseline and up to 6 months', 'description': "EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (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 score indicate high QoL. A positive change from baseline indicates better quality of life."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Mantle Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '41160777', 'type': 'DERIVED', 'citation': 'van Meerten T, Kersten MJ, Iacoboni G, Hess GR, Mutsaers PGNJ, Martin Garcia-Sancho AM, Goy A, Gine E, Hill BT, Weng WK, Reagan PM, Patel K, Galal A, Herbaux C, Sanderson R, Forcade E, Topp MS, Houot R, Zheng D, Zhang W, Kanska J, Shen RR, Damico Khalid R, Kloos I, Dreyling M, Wang ML. Brexucabtagene autoleucel for BTKi-naive relapsed/refractory mantle cell lymphoma: primary analysis of ZUMA-2 Cohort 3. Blood. 2025 Oct 29:blood.2025029734. doi: 10.1182/blood.2025029734. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=KTE-C19-102%20(Cohort%203)', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "Study KTE-C19-102 (NCT02601313) enrolled participants with r/r MCL who have been treated with up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and Cohort 2. However, to fulfill FDA Postmarketing Requirement Cohort 3 is added to the study. It will include participants with r/r MCL who have been treated with up to 5 prior regimens but have not received prior therapy with a BTKi.\n\nThe primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3 will be analyzed separately. Therefore, this separate registration is only for Cohort 3.\n\nAfter the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Up to 5 prior regimens for MCL. Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy. Individuals must not have received prior therapy with a BTKi.\n* At least 1 measurable lesion\n* Platelet count ≥ 75,000/uL\n* Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/min\n* 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\n* Baseline oxygen saturation \\> 92% on room air\n\nKey Exclusion Criteria:\n\n* Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing\n* 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\n* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04880434', 'acronym': 'ZUMA-2', 'briefTitle': 'Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma', 'orgStudyIdInfo': {'id': 'KTE-C19-102 (Cohort 3)'}, 'secondaryIdInfos': [{'id': '2015-005008-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brexucabtagene autoleucel (KTE-X19)', 'description': 'Participants with relapsed/refractory mantle cell lymphoma will receive conditioning chemotherapy consisting of fludarabine 30 mg/m\\^2/day and cyclophosphamide 500 mg/m\\^2/day intravenous (IV) infusion for 3 days followed by a single infusion of brexucabtagene autoleucel (KTE-X19) at a targeted dose of 2 x 10\\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg, with a maximum flat dose of 2 x 10\\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0 in Cohort 3.', 'interventionNames': ['Drug: Fludarabine', 'Drug: Cyclophosphamide', 'Biological: Brexucabtagene autoleucel']}], 'interventions': [{'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Brexucabtagene autoleucel (KTE-X19)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Brexucabtagene autoleucel (KTE-X19)']}, {'name': 'Brexucabtagene autoleucel', 'type': 'BIOLOGICAL', 'otherNames': ['KTE-X19', 'TECARTUS™'], 'description': 'A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells', 'armGroupLabels': ['Brexucabtagene autoleucel (KTE-X19)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'University California Los Angeles (UCLA)', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Sarah Cannon- Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Aurora Health - 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Taussig Cancer Institute', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43220', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon - Tenessee', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Cancer Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '44035', 'city': 'Pessac', 'country': 'France', 'facility': 'Hopital Haut-Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '55101', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg University Hospital-University Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Munich University of Technology-Medical Faculty- Ethics Committee', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '1100', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth University Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Kite Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kite, A Gilead Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kite, A Gilead Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}