[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06885424":3,"trial-entities:NCT06885424":113,"trial-summary:NCT06885424":125},{"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":34,"study_type":37,"primary_purpose":38,"phases":39,"enrollment_info":40,"interventions":43,"primary_outcomes":50,"secondary_outcomes":55,"sex":68,"minimum_age":69,"maximum_age":38,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":74,"locations":77,"central_contacts":102,"overall_officials":103,"references":108,"see_also_links":109},"NCT06885424","A2B101-201","A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products","A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2Bio) Gene Therapy (GT) Products","ENROLLING_BY_INVITATION","2040-03-31","2026-05","2026-05-20","2025-07-31","A2 Biotherapeutics Inc.","INDUSTRY",false,"This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.","This is a long-term follow-up study designed to evaluate delayed safety events and long-term efficacy of A2 Bio GT products for participants who received any amount of A2 Bio GT products in a previous interventional study. No further interventional treatment is administered in this study.\n\nParticipants will enroll in this long-term follow-up study upon completion of 2 years of follow-up in the assigned interventional study in which they received treatment. Participants will be followed for up to 15 years after administration of A2 Bio GT product. This study will collect long-term safety and efficacy data as outlined by the FDA guidance for long-term follow-up for GT products.",[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33],"Solid Tumor Cancer","Solid Tumor, Unspecified, Adult","Colorectal Carcinoma","Colorectal Carcinoma (CRC)","Non Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Pancreatic Cancer","NSCLC","Mesothelioma","Ovarian Cancer","Ovarian Carcinoma","Head and Neck (HNSCC)","Head and Neck Cancer","Renal Cell Carcinoma (Kidney Cancer)","Triple Negative Breast Cancer (TNBC)",[35,36],"CAR T Cell Therapy","Gene Therapy","OBSERVATIONAL",null,[],{"count":41,"type":42},400,"ESTIMATED",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48},"OTHER","No additional intervention administered in this long term follow-up study","Safety follow-up for A2 Bio GT products administered in a previous interventional study",[49],"Participants that received A2 Bio GT products",[51],{"measure":52,"description":53,"timeFrame":54},"Long-term safety of previous A2 Bio GT treatment","Long-term safety of previous A2 Bio GT treatment as determined by incidence of adverse events (AEs)","15 years post treatment with A2 Bio GT product",[56,59,62,65],{"measure":57,"description":58,"timeFrame":54},"Overall survival","The time from dosing of A2 Bio GT product to the date of death from any cause",{"measure":60,"description":61,"timeFrame":54},"Long-term durability of clinical effect of previous A2 Bio GT treatment","Long-term durability of clinical effect of previous A2 Bio GT treatment as measured by duration of response (DOR)",{"measure":63,"description":64,"timeFrame":54},"Progression Free Survival (PFS)","Time from dosing of A2 Bio GT products to the date of disease progression or death from any cause, whichever occurs earlier",{"measure":66,"description":67,"timeFrame":54},"Incidence of RCL detected in blood","RCL will be tested on blood by ddPCR as applicable based on FDA guidance","ALL","18 Years",{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"Inclusion Criteria:\n\n1. Received any amount of A2 Bio GT product on a previous A2 Bio interventional study\n2. Able to provide written informed consent for this long-term follow-up study\n3. Able to comply with study requirements\n\nExclusion Criteria:\n\n1\\. There are no specific exclusion criteria for this study",[75,76],"ADULT","OLDER_ADULT",[78,87,95],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Banner Health","Gilbert","Arizona","85234","United States",{"lat":85,"lon":86},33.35283,-111.78903,{"facility":88,"city":89,"state":90,"zip":91,"country":83,"geoPoint":92},"Mayo Clinic","Rochester","Minnesota","55905",{"lat":93,"lon":94},44.02163,-92.4699,{"facility":96,"city":97,"state":97,"zip":98,"country":83,"geoPoint":99},"NYU Langone Medical Center","New York","10016",{"lat":100,"lon":101},40.71427,-74.00597,[],[104],{"name":105,"affiliation":106,"role":107},"Eric Ng, MD","A2 Biotherapeutics","STUDY_DIRECTOR",[],[110],{"label":111,"url":112},"A2 Bio Website","http:\u002F\u002Fwww.a2bio.com",{"nct_id":4,"conditions":114,"biomarkers":124},[21,115,116,117,118,119,120,121,122,123],"Lung Non-Small Cell Carcinoma","Lung Small Cell Carcinoma","Malignant Head and Neck Neoplasm","Malignant Ovarian Neoplasm","Mesothelial Neoplasm","Pancreatic Carcinoma","Renal Cell Carcinoma","Solid Neoplasm","Triple-negative breast cancer",[],{"nct_id":4,"found":15,"summary":38,"prompt_version":38}]