[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07403188":3,"trial-entities:NCT07403188":106,"trial-summary:NCT07403188":113},{"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":25,"study_type":26,"primary_purpose":16,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":59,"sex":73,"minimum_age":74,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":75,"std_ages":82,"locations":85,"central_contacts":99,"overall_officials":103,"references":104,"see_also_links":105},"NCT07403188","KYV101-004","A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101","RECRUITING","2041-01","2026-02","2026-02-11","2025-11-24","Kyverna Therapeutics","INDUSTRY",false,"The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been administered KYV-101 (gene-modified product; autologous CAR T cell product).\n\nThis LTFU protocol will be open to any participant who received at least one infusion of KYV-101 in a previous Kyverna sponsored clinical trial or Investigator Initiated Trial (IIT).",null,[18,19,20,21,22,23,24],"Refractory Lupus Nephritis","Myasthaenia Gravis","Stiff Person Syndrome","Rheumatoid Arthritis (RA)","Multiple Sclerosis","Dermatomyositis","Systemic Sclerosis (SSc)",[],"OBSERVATIONAL",[],{"count":29,"type":30},70,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","KYV-101","Autologous fully-human anti-CD19 chimeric antigen receptor T-cell (CD19 CAR T) product.",[37],"Cohort 1",[39,42,44,46,48,50,52,55,57],{"measure":40,"timeFrame":41},"Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).","Up to 15 years from study entry",{"measure":43,"timeFrame":41},"Number of participants with new or recurrent malignancies as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).",{"measure":45,"timeFrame":41},"Number of participants with new or exacerbation of a pre-existing neurologic disorder as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).",{"measure":47,"timeFrame":41},"Number of participants with new or exacerbation of a prior rheumatologic or other autoimmune disorder as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).",{"measure":49,"timeFrame":41},"Number of participants with new hematologic disorders as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).",{"measure":51,"timeFrame":41},"Number of participants with new infections as assessed by CTCAE v6.0 through Year 15 of long-term follow-up (LTFU).",{"measure":53,"timeFrame":54},"Number of participants with positive Replication-Competent Lentivirus (RCL) laboratory test results through Year 5 of long-term follow-up (LTFU).","Up to 5 years from study entry",{"measure":56,"timeFrame":54},"Number of participants with positive Chimeric Antigen Receptor (CAR) laboratory test results through Year 5 of long-term follow-up (LTFU).",{"measure":58,"timeFrame":54},"Number of participants with positive Anti-Drug-Antibody (ADA) laboratory test results through Year 5 of long-term follow-up (LTFU).",[60,63,67,70],{"measure":61,"timeFrame":62},"For lupus nephritis participants, number of participants administered glucocorticoids and other immunosuppressants through Year 2 after KYV101 infusion.","Up to 2 years from first KYV-101 infusion",{"measure":64,"description":65,"timeFrame":66},"For stiff-person syndrome participants, change in time required (in seconds) to complete the Timed 25-foot Walk (T25-FW) through Year 4 of LTFU.","For stiff-person syndrome participants, change in time required (in seconds) from baseline to complete the Timed 25-foot Walk (T25-FW) test as assessed by the investigator through Year 4 of long-term follow-up (LTFU). The T25-FW test is a quantitative mobility and leg function performance test based on a timed 25-foot walk, with shorter times indicating better mobility and improved disease severity.","Up to 4 years from study entry",{"measure":68,"description":69,"timeFrame":54},"For myasthenia gravis participants, change in score on the Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire through Year 5 of LTFU.","For myasthenia gravis participants, change in score from baseline on the Myasthenia Gravis Activities of Daily Living (MG-ADL) questionnaire as assessed by the investigator through Year 5 of long-term follow-up (LTFU). The MG-ADL questionnaire is a quantitative functional status instrument, with scores ranging from 0 to 24, with a higher score indicating worse disease severity.",{"measure":71,"description":72,"timeFrame":54},"For myasthenia gravis participants, change in score on the Quantitative Myasthenia Gravis (QMG) questionnaire through Year 5 of LTFU.","For myasthenia gravis participants, change in score from baseline on the Quantitative Myasthenia Gravis (QMG) questionnaire as assessed by the investigator through Year 5 of long-term follow-up (LTFU). The QMG questionnaire is a quantitative muscle strength and endurance\u002Ffatigability instrument, with scores ranging from 0 to 39, with a higher score indicating worse disease severity.","ALL","18 Years",{"inclusion":76,"exclusion":79,"raw_text":81},[77,78],"Provided informed consent for the LTFU study","Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol",[80],"Not applicable","Inclusion Criteria:\n\n* Provided informed consent for the LTFU study\n* Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol\n\nExclusion Criteria:\n\n* Not applicable",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"status":7,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":96},"University of Colorado, Denver","Denver","Colorado","80045","United States",[93],{"name":94,"role":95},"Study Coordinator","CONTACT",{"lat":97,"lon":98},39.73915,-104.9847,[100],{"name":12,"role":95,"phone":101,"email":102},"510-925-2484","clinicaltrials@kyvernatx.com",[],[],[],{"nct_id":4,"conditions":107,"biomarkers":112},[23,108,22,109,110,20,111],"Lupus Glomerulonephritis","Myasthenia Gravis","Rheumatoid Arthritis","Systemic Scleroderma",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an observational study with a planned enrollment of 70 participants. It is a long-term follow-up study.","completed","Long-Term Follow-Up for KYV-101 Treatment","This study is a long-term follow-up for people who have previously received KYV-101, an autologous (using your own cells) anti-CD19 CAR T-cell product. KYV-101 is a type of gene-modified therapy. The study aims to understand any delayed side effects and how long KYV-101 stays in your body. You can join if you are 18 or older and have already received at least one dose of KYV-101 in a previous study. The study will track the number of participants who experience new side effects, new cancers, or new or worsening nerve problems over 15 years. The current status of this study is unclear.","Participants will be followed for up to 15 years from when they entered the study.",102,"Not specified in the trial record.","Not stated in the trial record.",[34],"v2"]