[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06882317":3,"trial-entities:NCT06882317":91,"trial-summary:NCT06882317":95},{"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":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":37,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":27,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":54,"locations":57,"central_contacts":83,"overall_officials":84,"references":89,"see_also_links":90},"NCT06882317","CBR-CLBR001-3002","Long Term Follow-up Study for Subjects Administered CLBR001","A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001","ENROLLING_BY_INVITATION","2044-02","2026-04","2026-04-08","2025-08-28","Calibr, a division of Scripps Research","OTHER",false,"The goal of this Long Term Follow-Up observational study is to monitor subjects who have received CLBR001, a lentiviral vector based chimeric antigen receptor, for delayed adverse events that may be associated with human gene therapies.\n\nParticipants will be followed for 15 years post-gene therapy administration date for safety and efficacy.","In line with FDA guidance on Long Term Follow-Up (LTFU) after administration of human gene therapy products, any subject who receives CLBR001 on any Calibr treatment study will participate in LTFU on this study. Subjects will be enrolled following completion on the applicable treatment study and followed for 15 years post-CLBR001 administration in order to assess the long term safety of CLBR001.",[19],"Long Term Follow-Up",[21,22,23,24,25],"Long Term Follow-Up (LTFU)","CLBR001","Autologous Cell Therapy","Switchable CAR-T Cell","Cell and Gene Therapy","OBSERVATIONAL",null,[],{"count":30,"type":31},40,"ESTIMATED",[33],{"type":14,"name":19,"description":34,"armGroupLabels":35},"No intervention is administered on this study. Subjects who have received CLBR001 autologous CAR-T cells in a primary Calibr treatment trial will be followed long term in line with FDA guidance.",[36],"CLBR001 Treated Subjects",[38,42],{"measure":39,"description":40,"timeFrame":41},"Number of subjects with adverse events as assessed by CTCAE v5.0.","To assess the long term safety of CLBR001 in subjects by evaluating the incidence, duration, and outcome of adverse events (including adverse events of special interest, CLBR001-related adverse events and serious adverse events), as assessed by CTCAE v5.0.","To 15 years post-CLBR001 administration.",{"measure":43,"description":44,"timeFrame":41},"Number of subjects with replication competent lentivirus (RCL).","To assess the long term safety of CLBR001 in subjects by evaluating the proportion of subjects with detectable RCL from CLBR001.",[],"ALL","18 Years",{"inclusion":49,"exclusion":51,"raw_text":53},[50],"Subjects who received at least one CLBR001 cell dose.",[52],"None","Inclusion Criteria:\n\n* Subjects who received at least one CLBR001 cell dose.\n\nExclusion Criteria:\n\n* None",[55,56],"ADULT","OLDER_ADULT",[58,67,75],{"facility":59,"city":60,"state":61,"zip":62,"country":63,"geoPoint":64},"Indiana University Melvin and Bren Simon Comprehensive Cancer Center","Indianapolis","Indiana","46202","United States",{"lat":65,"lon":66},39.76838,-86.15804,{"facility":68,"city":69,"state":70,"zip":71,"country":63,"geoPoint":72},"Virtual Research Group- Premier Research","Morrisville","North Carolina","27560",{"lat":73,"lon":74},35.82348,-78.82556,{"facility":76,"city":77,"state":78,"zip":79,"country":63,"geoPoint":80},"University of Virginia","Charlottesville","Virginia","22908",{"lat":81,"lon":82},38.02931,-78.47668,[],[85],{"name":86,"affiliation":87,"role":88},"Chief Medical Officer","Calibr-Skaggs Institute for Innovative Medicines","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"Post-Cell Therapy Status",[],{"nct_id":4,"found":15,"summary":27,"prompt_version":27}]