[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06701201":3,"trial-entities:NCT06701201":127,"trial-summary:NCT06701201":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":47,"sex":56,"minimum_age":57,"maximum_age":24,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":62,"locations":65,"central_contacts":123,"overall_officials":124,"references":125,"see_also_links":126},"NCT06701201","LTFU 101-00","A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product","ENROLLING_BY_INVITATION","2042-02","2026-01","2026-08-04","2025-01-27","Verismo Therapeutics","INDUSTRY",false,"The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.","This is a study for the Long Term Follow Up for all participants treated with Verismo Therapeutics' SynKIR CAR T cell products in accordance with regulatory guidance. The primary objective of this study is to monitor the long-term safety of SynKIR CAR T cell products.\n\nNo investigational product will be administered in this LTFU study. Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product under a Verismo Therapeutics parent protocol. Participants will be invited to enroll into this LTFU study after either early discontinuation from or completion of the parent protocol.\n\nIn accordance with regulatory guidelines, this study will follow participants for a period of 15 years following infusion of Verismo Therapeutics' SynKIR CAR T cell product, to monitor for delayed adverse events (AEs), detection of replication competent lentivirus (RCL), and to assess long-term efficacy and persistence of gene-modified T cells.",[18],"Cancer",[18,20,21,22],"CAR-T","CAR-T Cells","KIR-CAR","OBSERVATIONAL",null,[],{"count":27,"type":28},60,"ESTIMATED",[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","SynKIR-110","Autologous T cells Transduced with Mesothelin KIR-CAR",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38},"SynKIR-310","Autologous T Cells transduced with CD19 KIR-CAR",[36],[40,44],{"measure":41,"description":42,"timeFrame":43},"To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product","Frequency and severity of delayed AEs considered related to SynKIR CAR T cell product","Up to 15 years from SynKIR CAR T cell product administration",{"measure":45,"description":46,"timeFrame":43},"To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product","Presence of RCL VSV-G DNA",[48,51,53],{"measure":49,"description":50,"timeFrame":43},"To assess the long-term clinical efficacy of SynKIR CAR T cell product","Overall survival",{"measure":49,"description":52,"timeFrame":43},"Progression-free survival",{"measure":54,"description":55,"timeFrame":43},"To assess the persistence of SynKIR-modified T cells","Presence of a SynKIR CAR DNA sequence","ALL","18 Years",{"inclusion":59,"exclusion":60,"raw_text":61},[],[],"Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. All adult participants who have received any amount of SynKIR CAR T cell product in a study sponsored by Verismo Therapeutics.\n2. Participant is willing and able to comply with the study requirements.\n\nExclusion Criteria:\n\nThere are no specific exclusion criteria.",[63,64],"ADULT","OLDER_ADULT",[66,75,83,91,99,107,115],{"facility":67,"city":68,"state":69,"zip":70,"country":71,"geoPoint":72},"Colorado Blood Cancer Institute, part of Sarah Cannon Research Institute","Denver","Colorado","80218","United States",{"lat":73,"lon":74},39.73915,-104.9847,{"facility":76,"city":77,"state":78,"zip":79,"country":71,"geoPoint":80},"Winship Cancer Institute of Emory University","Atlanta","Georgia","30322",{"lat":81,"lon":82},33.749,-84.38798,{"facility":84,"city":85,"state":86,"zip":87,"country":71,"geoPoint":88},"University of Kansas Cancer Center","Westwood","Kansas","66205",{"lat":89,"lon":90},39.04056,-94.6169,{"facility":92,"city":93,"state":94,"zip":95,"country":71,"geoPoint":96},"Rutgers Cancer Institute","New Brunswick","New Jersey","08901",{"lat":97,"lon":98},40.48622,-74.45182,{"facility":100,"city":101,"state":102,"zip":103,"country":71,"geoPoint":104},"University of Pennsylvania Abramson Cancer Center","Philadelphia","Pennsylvania","19104",{"lat":105,"lon":106},39.95238,-75.16362,{"facility":108,"city":109,"state":110,"zip":111,"country":71,"geoPoint":112},"MD Anderson Cancer Center","Houston","Texas","77030",{"lat":113,"lon":114},29.76328,-95.36327,{"facility":116,"city":117,"state":118,"zip":119,"country":71,"geoPoint":120},"University of Wisconsin Carbone Cancer Center","Madison","Wisconsin","53792",{"lat":121,"lon":122},43.07305,-89.40123,[],[],[],[],{"nct_id":4,"conditions":128,"biomarkers":130},[129],"Malignant Neoplasm",[],{"nct_id":4,"found":14,"summary":24,"prompt_version":24}]