Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05822427
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2023-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Unless participants entering the study have three consecutive negative azer-cel persistence tests results when entering the study, participants will undergo persistence testing whilst on study untill three consecutive negative tests are confirmed.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2039-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-11', 'studyFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2023-04-10', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Clinically Significant Clinical Events of Interest (CEI)', 'timeFrame': 'Up to 15 years'}, {'measure': 'Severity of Clinically Significant CEI', 'timeFrame': 'Up to 15 years'}, {'measure': 'Duration of Clinically Significant CEI', 'timeFrame': 'Up to 15 years'}, {'measure': 'Outcome of Clinically Significant CEI', 'timeFrame': 'Up to 15 years'}], 'secondaryOutcomes': [{'measure': 'Duration of Disease Response', 'timeFrame': 'Up to 15 years'}, {'measure': 'Overall Survival Rate', 'timeFrame': 'Up to 15 years'}, {'measure': 'Azer-cel Persistence', 'timeFrame': 'Up to 15 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allogeneic chimeric antigen receptor (CAR) T cell products', 'azer-cel'], 'conditions': ['Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to collect information on the long-term safety of study participants who received an Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in an Imugene Clinical Study. The main questions it aims to answer are:\n\n* What are the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?\n* What is the duration of response and overall survival time after taking an allogeneic CAR T-Cell product on an Imugene clinical study?\n\nParticipants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.', 'detailedDescription': 'This is a Long-Term Follow-Up (LTFU) observational study designed primarily to collect data regarding CEI for up to 15 years following participation in an Imugene clinical study for subjects who received azer-cel. This study protocol does not include administration of azer-cel; however, subjects may receive standard of care treatment or investigational products other than azer-cel through participation in other clinical studies during the period of this observational study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any participant who has received a azer-cel in an Imugene clinical study can be enrolled into this LTFU study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receipt of at least 1 dose of azer-cel in an Imugene clinical study.\n* A signed informed consent form (ICF).\n* Willingness and ability to adhere to the study schedule and all other protocol requirements.\n\nExclusion Criteria:\n\n* No unique exclusion criteria apply to this study.'}, 'identificationModule': {'nctId': 'NCT05822427', 'briefTitle': 'Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Imugene Limited'}, 'officialTitle': 'Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study', 'orgStudyIdInfo': {'id': 'PBCAR-LTF'}}, 'contactsLocationsModule': {'locations': [{'zip': '90230', 'city': 'Culver City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Science 37, Inc.', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}], 'centralContacts': [{'name': 'Clinical Imugene Limited', 'role': 'CONTACT', 'email': 'info@imugene.com', 'phone': '1 984 245 0082'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imugene Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}