[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556684":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":180,"collaborators":24,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":24,"eligibilityCriteria":188,"healthyVolunteers":184,"sex":189,"minAge":190,"maxAge":24,"enrollmentInfo":191,"targetDuration":24,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":203,"overallStatus":68,"whyStopped":24,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Umoja Biopharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"UB-VV111","EXPERIMENTAL","A single dose of UB-VV111 will be administered.",[13],"Genetic: UB-VV111",{"label":15,"type":10,"description":16,"interventionNames":17},"UB-VV111 + rapamycin","A single dose of UB-VV111 will be administered followed by treatment with rapamycin.",[13,18],"Drug: rapamycin",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"GENETIC","UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.",[9,15],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","rapamycin","Rapamycin is an FDA-approved drug.",[15],[31],"Rapamune, sirolimus",[33],{"name":34,"affiliation":5,"role":35},"Jacob Garcia, MD","STUDY_DIRECTOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":24,"email":40},"CONTACT","425-873-8331","jacob.garcia@umoja-biopharma.com",{"name":42,"role":38,"phone":24,"phoneExt":24,"email":43},"Christine Dehner","christine.dehner@umoja-biopharma.com",[45,66,83,100,117,134,151,163],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"City of Hope","NOT_YET_RECRUITING","Duarte","California","91010","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-117.97729,34.13945,{"lat":57,"lon":56},[60,64],{"name":61,"role":38,"phone":62,"phoneExt":24,"email":63},"Tanya Siddiqi, MD","626-218-2405","tsiddiqi@coh.org",{"name":61,"role":65,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":51,"countryCode":52,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"The David and Etta Jonas Center for Cellular Therapy","RECRUITING","Chicago","Illinois","60637",{"type":54,"coordinates":73},[74,75],-87.65005,41.85003,{"lat":75,"lon":74},[78,82],{"name":79,"role":38,"phone":80,"phoneExt":24,"email":81},"Michael Bishop, MD","773-702-6149","cancerclinicaltrials@bsd.uchicago.edu",{"name":79,"role":65,"phone":24,"phoneExt":24,"email":24},{"facility":84,"status":68,"city":85,"state":86,"zip":87,"country":51,"countryCode":52,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Washington University School of Medicine\u002FSiteman Cancer Center","St Louis","Missouri","63110",{"type":54,"coordinates":89},[90,91],-90.19789,38.62727,{"lat":91,"lon":90},[94,98],{"name":95,"role":38,"phone":96,"phoneExt":24,"email":97},"Yalda Karamlou","314-273-3776","yalda@wustl.edu",{"name":99,"role":65,"phone":24,"phoneExt":24,"email":24},"Zachary Crees, MD",{"facility":101,"status":68,"city":102,"state":103,"zip":104,"country":51,"countryCode":52,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"University of Nebraska Medical Center","Omaha","Nebraska","68198-6814",{"type":54,"coordinates":106},[107,108],-95.94043,41.25626,{"lat":108,"lon":107},[111,115],{"name":112,"role":38,"phone":113,"phoneExt":24,"email":114},"Brooke Tridle, MHA","402-559-5101","brtridle@unmc.edu",{"name":116,"role":65,"phone":24,"phoneExt":24,"email":24},"Matthew Lunning, D.O. F.A.C.P.",{"facility":118,"status":68,"city":119,"state":120,"zip":121,"country":51,"countryCode":52,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"University of Cincinnatti Medical Center","Cincinnati","Ohio","45219",{"type":54,"coordinates":123},[124,125],-84.51439,39.12711,{"lat":125,"lon":124},[128,132],{"name":129,"role":38,"phone":130,"phoneExt":24,"email":131},"Hani Alrefai, MBBCh, MS, PhD","513-584-8438","alrefahd@ucmail.uc.edu",{"name":133,"role":65,"phone":24,"phoneExt":24,"email":24},"Zulfa Omer, MD",{"facility":135,"status":68,"city":136,"state":137,"zip":138,"country":51,"countryCode":52,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Fred Hutch Cancer Center","Seattle","Washington","98109",{"type":54,"coordinates":140},[141,142],-122.33207,47.60621,{"lat":142,"lon":141},[145,149],{"name":146,"role":38,"phone":147,"phoneExt":24,"email":148},"Shelby Colden","206-667-5134","scolden2@fredhutch.org",{"name":150,"role":65,"phone":24,"phoneExt":24,"email":24},"Ajay Gopal, MD\u002FFACP",{"facility":152,"status":68,"city":153,"state":154,"zip":155,"country":156,"countryCode":157,"cosmosGeoPoint":24,"geoPoint":24,"contacts":158},"Royal North Shore Hospital","Saint Leonards","New South Wales","2065","Australia","AU",[159,162],{"name":160,"role":38,"phone":161,"phoneExt":24,"email":24},"Cameron Turtle, MBBS, PhD","+61299264377",{"name":160,"role":65,"phone":24,"phoneExt":24,"email":24},{"facility":164,"status":68,"city":165,"state":166,"zip":167,"country":156,"countryCode":157,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"St. Vincent's Hospital Melbourne","Fitzroy","Victoria","3065",{"type":54,"coordinates":169},[170,171],144.97833,-37.79839,{"lat":171,"lon":170},[174,178],{"name":175,"role":38,"phone":176,"phoneExt":24,"email":177},"Joseph Nguyen-Vo","+61 3 9231 3263","Joseph.Nguyen@svha.org.au",{"name":179,"role":65,"phone":24,"phoneExt":24,"email":24},"Matthew Ku, MD",{"type":181,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100556684","phase-1-a-phase-1-study-of-ub-vv111-with-and-without-rapamycin-in-relapsedrefractory-cd19-b-cell-malignancies-100556684",false,"NCT06528301","A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed\u002FRefractory CD19+ B-cell Malignancies","A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed\u002FRefractory (R\u002FR) CD19+ B-cell Malignancies","Inclusion Criteria:\n\n1. 18 years or older\n2. Provides voluntary written informed consent\n3. Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)\n4. Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).\n5. No serious concomitant diseases or active\u002Funcontrolled infections\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate organ function\n8. Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding\n2. Current isolated central nervous system (CNS) involvement\n3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (exceptions include tumor-infiltrating lymphocytes and CAR T cells)\n4. History of or active human immunodeficiency virus (HIV)\n5. Active hepatitis B or C\n6. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease\n7. Ongoing CNS disease that would preclude neurologic assessment\n8. Uncontrolled angina or other acute heart disease\n9. Currently receiving treatment in another interventional clinical trial.","ALL","18 Years",{"count":192,"type":193},106,"ESTIMATED","INTERVENTIONAL",[196],"PHASE1","This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed\u002Frefractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).",[199,200,201,202],"Lymphoma, B-Cell","Lymphoma, Non-Hodgkin (NHL)","Lymphoma, Large B-Cell, Diffuse (DLBCL)","Chronic Lymphocytic Leukemia (CLL)",[204,205,206],"CAR T","CD19","chimeric antigen receptor","2026-05-26",{"date":209,"type":210},"2026-05-28","ACTUAL",{"date":212,"type":210},"2025-03-10",{"date":214,"type":193},"2029-03",{"name":5,"class":6},8]