[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05472649":3,"trial-entities:NCT05472649":75,"trial-summary:NCT05472649":78},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":47,"minimum_age":23,"maximum_age":23,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":54,"locations":58,"central_contacts":68,"overall_officials":69,"references":73,"see_also_links":74},"NCT05472649","CGT-LTFU-351","Long-Term Follow-Up of Patients Who Received Gene-Modified Cell Therapy","Long-Term Follow-Up Study of Patients Who Have Received Gene-Modified Cell Therapy or Gene Therapy in Trials Sponsored By Sorrento Therapeutics, INC.","ENROLLING_BY_INVITATION","2037-05","2023-01","2023-01-23","2021-06-16","Sorrento Therapeutics, Inc.","INDUSTRY",false,"Observational long-term follow-up study of patients who have been exposed to a gene-modified cell therapy produced by ex vivo transduction of immune cells expressing viral or non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc.","Study CGT-LTFU-35 is an observational study of patients who have been exposed to a gene-modified cell therapy (GMCT) produced by ex vivo transduction of immune cells expressing viral and\u002For non-viral vectors in studies sponsored by Sorrento Therapeutics, Inc. Patients are to be followed for up to 15 years after exposure to a GMCT agent for the possible development of long-term adverse events and efficacy outcomes.",[19],"Long-term Follow-up",[21],"long-term follow up","OBSERVATIONAL",null,[],{"count":26,"type":27},1,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BIOLOGICAL","Gene-Modified Cell Therapy","No investigational cell product will be administered",[34],"Participants exposed to Gene-Modified Cell Therapy",[36],{"measure":37,"description":38,"timeFrame":39},"Long-term safety of previous treatment with gene-modified cells","Long-term safety of previous treatment as assessed by incidence of adverse events (AEs)","Baseline through end of study (approximately 15 years)",[41,44],{"measure":42,"description":43,"timeFrame":39},"Long-term durability of clinical effect of previous treatment with gene-modified cells","Long-term durability of clinical effect of previous treatment with gene-modified cells as assessed by duration of response (DOR)",{"measure":45,"description":46,"timeFrame":39},"Long-term durability of previous treatment with gene modified cells","Long-term durability as assessed by progression-free survival (PFS)","ALL",{"inclusion":49,"exclusion":51,"raw_text":53},[50],"Patients must have received any amount of a CGT in a study sponsored by Sorrento Therapeutics, Inc.",[52],"Unable or unwilling to provide written informed consent and\u002For comply with study requirements.","Inclusion Criteria:\n\n* Patients must have received any amount of a CGT in a study sponsored by Sorrento Therapeutics, Inc.\n\nExclusion Criteria:\n\n* Unable or unwilling to provide written informed consent and\u002For comply with study requirements.",[55,56,57],"CHILD","ADULT","OLDER_ADULT",[59],{"facility":60,"city":61,"state":62,"zip":63,"country":64,"geoPoint":65},"Abramson Cancer Center Clinical Research Unit, University of Pennsylvania","Philadelphia","Pennsylvania","19104","United States",{"lat":66,"lon":67},39.95238,-75.16362,[],[70],{"name":71,"affiliation":13,"role":72},"Mike Royal, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":76,"biomarkers":77},[19],[],{"nct_id":4,"found":15,"summary":23,"prompt_version":23}]