Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT05776134
Status:
AVAILABLE
Last Update Posted:
2025-01-10
First Post:
2023-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], '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'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705347', 'term': 'brexucabtagene autoleucel'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-03-17', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Mantle Cell Lymphoma', 'Acute Lymphoblastic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=KT-US-472-0141', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have commercially manufactured brexucabtagene autoleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)\n* Deemed medically fit and stable to receive the product per the investigator's evaluation\n* Repeat leukapheresis is not feasible per the investigator's assessment\n* Be diagnosed with 1 of the approved labeled indications for brexucabtagene autoleucel that is intended for release\n* In the Investigator's opinion, there is no satisfactory alternative therapy available to the individual\n\nExclusion Criteria:\n\n* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as brexucabtagene autoleucel\n* Uncontrolled active infection or inflammation per physician assessment\n* Primary central nervous system (CNS) lymphoma"}, 'identificationModule': {'nctId': 'NCT05776134', 'briefTitle': 'Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel', 'orgStudyIdInfo': {'id': 'KT-US-472-0141'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Brexucabtagene Autoleucel', 'type': 'BIOLOGICAL', 'otherNames': ['Tecartus™'], 'description': 'A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35234', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Northside Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'status': 'AVAILABLE', 'country': 'United States', 'facility': "St. Luke's Cancer Institute", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'The University of Kansas Medical Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'University of Maryland Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute - Chestnut Hill', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Washington University School of Medicine- Siteman Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Weill Cornell Medicine - NewYork-Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Montefiore Medical Center (MMC)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'UNC Hospitals, The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43201', 'city': 'Columbus', 'state': 'Ohio', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Avera Cancer Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Sarah Canon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Vanderbilt-Ingrim Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '782229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Methodist Healthcare System of San Antonio dba Methodist Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Huntsman Cancer Institute, University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '53227', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Medical Information', 'role': 'CONTACT', 'email': 'medinfo@kitepharma.com', 'phone': '844-454-5483(1-844-454-KITE)'}], 'overallOfficials': [{'name': 'Kite Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kite, A Gilead Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kite, A Gilead Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}