[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468248":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":35,"responsibleParty":90,"collaborators":10,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":10,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":10,"maxAge":10,"enrollmentInfo":100,"targetDuration":10,"studyType":103,"phases":10,"briefSummary":104,"conditions":105,"keywords":111,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Pell Bio-Med Technology Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A",null,"After completion or early withdraw from the treatment protocol, patients will be enrolled into this long-term follow-up study. If patients do not enter this study right after leaving the treatment protocol, they may have the option to enter this study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion.",[13],"Genetic: Pell's lentiviral-based gene-edited immune cell therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B","Some patients may require joining other Pell's gene-edited immune cell therapy study during participating in this long-term follow-up study. For such case, the patient could be enrolled into the new treatment protocol. Meanwhile, the patient can be remaining in this long-term follow-up protocol as an inactive participant.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"GENETIC","Pell's lentiviral-based gene-edited immune cell therapy","No study drug or other planned treatment will be administered. Subjects who previously received Pell's lentiviral-based gene-edited immune cell therapy will be evaluated the safety and efficacy.",[9,15],[25],{"name":26,"affiliation":5,"role":27},"Chen-Lung Lin, MD","STUDY_CHAIR",[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Cherry Lo, MSC","CONTACT","886-2-8791-1789","3111","cherry.lo@pellbmt.com",[36,47,60,69,81],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":40,"countryCode":42,"cosmosGeoPoint":10,"geoPoint":10,"contacts":43},"Kaohsiung Medical University Chung-Ho Memorial Hospital","RECRUITING","Kaohsiung","Taiwan","807377","TW",[44],{"name":45,"role":46,"phone":10,"phoneExt":10,"email":10},"Yi-Chang Liu","PRINCIPAL_INVESTIGATOR",{"facility":48,"status":38,"city":49,"state":40,"zip":50,"country":40,"countryCode":42,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"National Taiwan University Hospital","Taipei","10025",{"type":52,"coordinates":53},"Point",[54,55],121.52639,25.05306,{"lat":55,"lon":54},[58],{"name":59,"role":46,"phone":10,"phoneExt":10,"email":10},"Shang-Ju Wu",{"facility":61,"status":38,"city":49,"state":40,"zip":62,"country":40,"countryCode":42,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Taipei Veterans General Hospital","112201",{"type":52,"coordinates":64},[54,55],{"lat":55,"lon":54},[67],{"name":68,"role":46,"phone":10,"phoneExt":10,"email":10},"Jyh-Pyng Gau",{"facility":70,"status":38,"city":71,"state":10,"zip":72,"country":40,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Chi Mei Medical Center","Tainan","710",{"type":52,"coordinates":74},[75,76],120.21333,22.99083,{"lat":76,"lon":75},[79],{"name":80,"role":46,"phone":10,"phoneExt":10,"email":10},"Hung-Chang Wu",{"facility":82,"status":38,"city":49,"state":10,"zip":83,"country":40,"countryCode":42,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Taipei Medical University - Taipei Medical University Hospital","11031",{"type":52,"coordinates":85},[54,55],{"lat":55,"lon":54},[88],{"name":89,"role":31,"phone":10,"phoneExt":10,"email":10},"Chao-Hua Chiu",{"type":91,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100468248","long-term-follow-up-study-of-lentiviral-based-gene-edited-immune-cell-therapy-100468248",false,"NCT05377307","Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy","Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy","Inclusion Criteria:\n\n1. Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials.\n2. The last lentiviral-based gene-edited immune cell infusion within 15 years.\n3. Patient\u002Fpatient's parent\u002Flegal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\nThere are no specific exclusion criteria for this study.","ALL",{"count":101,"type":102},49,"ESTIMATED","OBSERVATIONAL","According to health authorities guidances (FDA 2006, EMA(European Medicines Agency) 2009) for gene therapy clinical trials, observing subjects for delayed adverse events for 15 years is recommended. This purpose of this long-term follow-up study is to evaluate the safety and efficacy in patients who have ever received lentiviral-based gene-edited immune cells which are manufactured by Pell Bio-Med Technology Co. Ltd.",[106,107,108,109,110],"Diffuse Large B Cell Lymphoma","Large B-cell Lymphoma","Primary Mediastinal Large B Cell Lymphoma","Follicular Lymphoma Grade 3A","Follicular Lymphoma Grade 3B",[112,113,114],"DLBCL(Diffuse Large B Cell Lymphoma)","PMLBCL(Primary Mediastinal Large B Cell Lymphoma)","FL(Follicular Lymphoma)","2025-05-07",{"date":117,"type":118},"2025-05-13","ACTUAL",{"date":120,"type":118},"2022-12-29",{"date":122,"type":102},"2037-12",{"name":5,"class":6},5]