[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04786262":3,"trial-entities:NCT04786262":302,"trial-summary:NCT04786262":306},{"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":15,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":51,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":81,"locations":84,"central_contacts":286,"overall_officials":292,"references":293,"see_also_links":301},"NCT04786262","VX20-880-101","A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes","A Master Protocol to Evaluate the Safety, Tolerability, and Efficacy of Islet Cell Replacement Therapies in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia: A Phase 1\u002F2\u002F3 Study of VX-880 and a Phase 1\u002F2 Study of VX-017","RECRUITING","2031-12-31","2026-08","2026-09-01","2021-03-29","Vertex Pharmaceuticals Incorporated","INDUSTRY",null,"This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.",[18,19,20],"Diabetes Mellitus, Type 1","Impaired Hypoglycemic Awareness","Severe Hypoglycemia",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},57,"ESTIMATED",[30,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BIOLOGICAL","VX-880","Infused into the hepatic portal vein.",[32],[36,37],"Zimislecel","Formerly known as STx-02",{"type":31,"name":39,"description":33,"armGroupLabels":40},"VX-017",[39],[42,45,48],{"measure":43,"timeFrame":44},"Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)","From VX-880 infusion to end of study (at least 5 years)",{"measure":46,"timeFrame":47},"Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)","1 year after achieving insulin independence (following VX-880 infusion)",{"measure":49,"timeFrame":50},"Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)","From VX-017 infusion to end of study (at least 5 years)",[52,55,58,60,62,65],{"measure":53,"timeFrame":54},"Parts B and C: Proportion of Participants who are Insulin Independent","At 1 year after VX-880 infusion",{"measure":56,"timeFrame":57},"Parts B and C: Proportion of Participants Free from SHEs with a Glycated Hemoglobin (HbA1c) less than (\u003C) 7.0%","SHEs: from Day 90 through 1 year (inclusive) after VX-880 infusion; HbA1c \u003C 7% at 1 year after VX-880 infusion",{"measure":59,"timeFrame":54},"Parts B and C: Change From Baseline in Glycated Hemoglobin (HbA1c)",{"measure":61,"timeFrame":44},"Parts B and C: Proportion of Participants Who Maintain Insulin Independence for at least 1 year",{"measure":63,"timeFrame":64},"Parts B and C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)","From VX-880 infusion up to end of study (at least 5 years)",{"measure":66,"timeFrame":67},"Part D: Change from baseline in peak C-peptide during mixed-meal tolerance test (MMTT)","At Day 90 after VX-017 infusion","ALL","18 Years","65 Years",false,{"inclusion":73,"exclusion":78,"raw_text":80},[74,75,76,77],"Clinical history of T1D with \\>=5 years of duration of insulin dependence","At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment","Stable diabetic treatment","Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study",[79],"Prior islet cell transplant, organ transplant, or cell therapy","Key Inclusion Criteria:\n\n* Clinical history of T1D with \\>=5 years of duration of insulin dependence\n* At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment\n* Stable diabetic treatment\n* Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study\n\nKey Exclusion Criteria:\n\n-Prior islet cell transplant, organ transplant, or cell therapy\n\nOther protocol-defined Inclusion\u002FExclusion criteria may apply",[82,83],"ADULT","OLDER_ADULT",[85,94,101,109,118,122,130,138,146,153,161,169,177,184,190,196,202,209,215,222,229,236,243,250,253,260,268,274,280],{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":90,"geoPoint":91},"City of Hope","Duarte","California","91010","United States",{"lat":92,"lon":93},34.13945,-117.97729,{"facility":95,"status":8,"city":96,"state":88,"zip":97,"country":90,"geoPoint":98},"University of California San Francisco","San Francisco","94143",{"lat":99,"lon":100},37.77493,-122.41942,{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":90,"geoPoint":106},"UHealth Diabetes Research Institute","Miami","Florida","33136",{"lat":107,"lon":108},25.77427,-80.19366,{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":90,"geoPoint":115},"Northwestern Organ Transplant Center","COMPLETED","Chicago","Illinois","60611",{"lat":116,"lon":117},41.85003,-87.65005,{"facility":119,"status":8,"city":112,"state":113,"zip":120,"country":90,"geoPoint":121},"University of Chicago","60637",{"lat":116,"lon":117},{"facility":123,"status":111,"city":124,"state":125,"zip":126,"country":90,"geoPoint":127},"Johns Hopkins University","Baltimore","Maryland","21287",{"lat":128,"lon":129},39.29038,-76.61219,{"facility":131,"status":8,"city":132,"state":133,"zip":134,"country":90,"geoPoint":135},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":136,"lon":137},42.35843,-71.05977,{"facility":139,"status":8,"city":140,"state":141,"zip":142,"country":90,"geoPoint":143},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"lat":144,"lon":145},39.95238,-75.16362,{"facility":147,"status":8,"city":148,"state":141,"zip":149,"country":90,"geoPoint":150},"University of Pittsburgh Medical Center Montefiore","Pittsburgh","15213",{"lat":151,"lon":152},40.44062,-79.99589,{"facility":154,"status":8,"city":155,"state":156,"zip":157,"country":90,"geoPoint":158},"Baylor Scott and White Research Institute","Dallas","Texas","75246",{"lat":159,"lon":160},32.78306,-96.80667,{"facility":162,"status":8,"city":163,"state":164,"zip":165,"country":90,"geoPoint":166},"VCU Medical Center, Richmond","Richmond","Virginia","23298",{"lat":167,"lon":168},37.55376,-77.46026,{"facility":170,"status":8,"city":171,"state":172,"zip":173,"country":90,"geoPoint":174},"University of Wisconsin","Madison","Wisconsin","53792",{"lat":175,"lon":176},43.07305,-89.40123,{"facility":178,"status":8,"city":179,"country":180,"geoPoint":181},"University of Alberta, Edmonton","Edmonton","Canada",{"lat":182,"lon":183},53.55014,-113.46871,{"facility":185,"status":8,"city":186,"country":180,"geoPoint":187},"McGill University Health Centre","Montreal",{"lat":188,"lon":189},45.50884,-73.58781,{"facility":191,"status":8,"city":192,"country":180,"geoPoint":193},"Toronto General Hospital (TGH)","Toronto",{"lat":194,"lon":195},43.70643,-79.39864,{"facility":197,"status":8,"city":198,"country":180,"geoPoint":199},"Vancouver General Hospital","Vancouver",{"lat":200,"lon":201},49.24966,-123.11934,{"facility":203,"status":8,"city":204,"country":205,"geoPoint":206},"CHU Lille","Lille","France",{"lat":207,"lon":208},50.63391,3.05512,{"facility":210,"status":8,"city":211,"country":205,"geoPoint":212},"Centre de recherche en Biomédecine de Strasbourg","Strasbourg",{"lat":213,"lon":214},48.58392,7.74553,{"facility":216,"status":8,"city":217,"country":218,"geoPoint":219},"Dresden Center for Islet Transplantation","Dresden","Germany",{"lat":220,"lon":221},51.05089,13.73832,{"facility":223,"status":8,"city":224,"country":225,"geoPoint":226},"IRCCS Ospedale San Raffaele","Milan","Italy",{"lat":227,"lon":228},45.46427,9.18951,{"facility":230,"status":8,"city":231,"country":232,"geoPoint":233},"Leiden University","Leiden","Netherlands",{"lat":234,"lon":235},52.15833,4.49306,{"facility":237,"status":8,"city":238,"country":239,"geoPoint":240},"Oslo University Hospital","Oslo","Norway",{"lat":241,"lon":242},59.91273,10.74609,{"facility":244,"status":8,"city":245,"country":246,"geoPoint":247},"King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology","Riyadh","Saudi Arabia",{"lat":248,"lon":249},24.68773,46.72185,{"facility":251,"status":8,"city":245,"country":246,"geoPoint":252},"King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology",{"lat":248,"lon":249},{"facility":254,"status":111,"city":255,"country":256,"geoPoint":257},"Hopiteaux Universitaires de Geneve","Geneva","Switzerland",{"lat":258,"lon":259},46.20222,6.14569,{"facility":261,"status":8,"city":262,"state":263,"country":264,"geoPoint":265},"Churchill Hospital","Headington","Oxford","United Kingdom",{"lat":266,"lon":267},51.75737,-1.21974,{"facility":269,"status":8,"city":270,"country":264,"geoPoint":271},"Royal Infirmary of Edinburgh","Edinburgh",{"lat":272,"lon":273},55.95206,-3.19648,{"facility":275,"status":8,"city":276,"country":264,"geoPoint":277},"Cardiovascular, Metabolic Medicine and Sciences, King's College London","London",{"lat":278,"lon":279},51.50853,-0.12574,{"facility":281,"status":8,"city":282,"country":264,"geoPoint":283},"The Newcastle upon Tyne Hospitals NHS Foundation Trust","Newcastle upon Tyne",{"lat":284,"lon":285},54.97328,-1.61396,[287],{"name":288,"role":289,"phone":290,"email":291},"Medical Information","CONTACT","617-341-6777","medicalinfo@vrtx.com",[],[294,298],{"pmid":295,"type":296,"citation":297},"41202120","DERIVED","Brown ME, Barra JM, Pina MR, Proia J, Brusko TM, Russ HA. Human stem cell-derived beta cells expressing an optimized CD155 reduce cytotoxic immune cell function for application in type 1 diabetes. Sci Adv. 2025 Nov 7;11(45):eadx9755. doi: 10.1126\u002Fsciadv.adx9755. Epub 2025 Nov 7.",{"pmid":299,"type":296,"citation":300},"40544428","Reichman TW, Markmann JF, Odorico J, Witkowski P, Fung JJ, Wijkstrom M, Kandeel F, de Koning EJP, Peters AL, Mathieu C, Kean LS, Bruinsma BG, Wang C, Mascia M, Sanna B, Marigowda G, Pagliuca F, Melton D, Ricordi C, Rickels MR; VX-880-101 FORWARD Study Group. Stem Cell-Derived, Fully Differentiated Islets for Type 1 Diabetes. N Engl J Med. 2025 Sep 4;393(9):858-868. doi: 10.1056\u002FNEJMoa2506549. Epub 2025 Jun 20.",[],{"nct_id":4,"conditions":303,"biomarkers":305},[304],"Type 1 Diabetes Mellitus",[],{"nct_id":4,"found":307,"summary":308,"prompt_version":318},true,{"design":309,"status":310,"heading":311,"summary":312,"follow_up":313,"word_count":314,"commitments":315,"compensation":316,"drugs_mentioned":317},"This interventional study is evaluating VX-880. The phase is not specified, and it plans to enroll 52 participants.","completed","Study of VX-880 for Type 1 Diabetes with Severe Hypoglycemia","This study is testing a treatment called VX-880 for people with Type 1 diabetes (T1D) who also experience impaired awareness of hypoglycemia (low blood sugar) and severe hypoglycemia. VX-880 is given by infusion into a vein near the liver. The study aims to see how safe VX-880 is and if it helps participants become independent from insulin and avoid severe low blood sugar events. To join, you must be 18 to 65 years old, have had T1D for over 5 years, experienced at least two severe low blood sugar episodes in the past year, and consistently use a continuous glucose monitor (CGM). The current status of the study is unclear, and it plans to enroll 52 participants.","Your safety and tolerability will be monitored for up to 5 years after the VX-880 infusion. If you become insulin independent, you will be followed for 1 year after that point to check for severe hypoglycemic events.",117,"You would receive an infusion of VX-880. You would also need to consistently use a continuous glucose monitor (CGM) for the entire study duration.","Not stated in the trial record.",[32],"v2"]