[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502451":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":30,"armGroups":11,"interventions":11,"overallOfficials":11,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":11,"id":54,"slug":11,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":11,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":11,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Imugene Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":11},[9,13,15,17],{"measure":10,"description":11,"timeFrame":12},"Frequency of Clinically Significant Clinical Events of Interest (CEI)",null,"Up to 15 years",{"measure":14,"description":11,"timeFrame":12},"Severity of Clinically Significant CEI",{"measure":16,"description":11,"timeFrame":12},"Duration of Clinically Significant CEI",{"measure":18,"description":11,"timeFrame":12},"Outcome of Clinically Significant CEI",[20,22,24],{"measure":21,"description":11,"timeFrame":12},"Duration of Disease Response",{"measure":23,"description":11,"timeFrame":12},"Overall Survival Rate",{"measure":25,"description":11,"timeFrame":12},"Azer-cel Persistence",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":27,"timePerspective":28,"maskingInfo":11},"COHORT","PROSPECTIVE","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.","Any participant who has received a azer-cel in an Imugene clinical study can be enrolled into this LTFU study.",[32],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},"Clinical Imugene Limited","CONTACT","1 984 245 0082","info@imugene.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":11},"Science 37, Inc.","RECRUITING","Culver City","California","90230","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.39647,34.02112,{"lat":50,"lon":49},{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100502451",false,"NCT05822427","Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study","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.","ALL","18 Years",{"count":62,"type":63},75,"ESTIMATED","OBSERVATIONAL","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.",[67],"Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study",[69,70],"Allogeneic chimeric antigen receptor (CAR) T cell products","azer-cel","2025-05-11",{"date":73,"type":74},"2025-05-14","ACTUAL",{"date":76,"type":74},"2020-08-25",{"date":78,"type":63},"2039-12",{"name":5,"class":6},1]