Viewing Study NCT05776160

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Ignite Creation Date: 2025-12-25 @ 2:01 AM
Ignite Modification Date: 2026-03-09 @ 2:44 PM
Study NCT ID: NCT05776160
Status: AVAILABLE
Last Update Posted: 2025-12-01
First Post: 2023-03-03
Is NOT Gene Therapy: True
Has Adverse Events: False
Brief Title: Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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': 'C000629083', 'term': 'axicabtagene ciloleucel'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-03-17', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Large B-cell Lymphoma', 'Follicular Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT05776160', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, 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 axicabtagene ciloleucel 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 axicabtagene ciloleucel 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 axicabtagene ciloleucel\n* Uncontrolled active infection or inflammation per physician assessment\n* Primary central nervous system lymphoma"}, 'identificationModule': {'nctId': 'NCT05776160', 'briefTitle': 'Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel', 'orgStudyIdInfo': {'id': 'KT-US-471-0140'}, 'secondaryIdInfos': [{'id': 'jRCT2033230370', 'type': 'OTHER', 'domain': 'Japan Registry of Clinical Trials'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Axicabtagene Ciloleucel', 'type': 'DRUG', 'otherNames': ['Yescarta®'], 'description': 'A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', '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 Medical Center', '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 Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'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 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'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': 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{'zip': '446-8602', 'city': 'Aichi', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Anjo Kosei Hospital', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '460-0001', 'city': 'Aichi', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Nagoya Medical Center', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '467-8602', 'city': 'Aichi', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Nagoya City University Hospital', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '480-1195', 'city': 'Aichi', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Aichi Medical University Hospital', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '010-8543', 'city': 'Akita', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Akita University Hospital', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': '260-8677', 'city': 'Chiba', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Chiba University Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '791-0295', 'city': 'Ehime', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Ehime University Hospital'}, {'zip': '910-1193', 'city': 'Fukui', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'University of Fukui Hospital', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'zip': '802-8555', 'city': 'Fukuoka', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Kokura Kinen Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '810-0072', 'city': 'Fukuoka', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Hamanomachi Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '810-8563', 'city': 'Fukuoka', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Kyushu Medical Center', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '812-8582', 'city': 'Fukuoka', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': 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'AVAILABLE', 'country': 'Japan', 'facility': 'Hokkaido University Hospital'}, {'zip': '650-0017', 'city': 'Hyōgo', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Kobe University Hospital', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '650-0047', 'city': 'Hyōgo', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Kobe City Medical Center General Hospital', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '663-8501', 'city': 'Hyōgo', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Hyogo Medical University Hospital', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '305-8576', 'city': 'Ibaraki', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'University of Tsukuba Hospital', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '761-0793', 'city': 'Kagawa', 'status': 'AVAILABLE', 'country': 'Japan', 'facility': 'Kagawa University Hospital', 'geoPoint': {'lat': 34.06667, 'lon': 131.03333}}, {'zip': '890-8520', 'city': 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