[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633294":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":25,"armGroups":21,"interventions":26,"overallOfficials":21,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":21,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":21,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":21,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":40,"whyStopped":21,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"N.N. Alexandrov National Cancer Centre","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"ORR","metabolic response evaluated by 2-deoxy-\\[18F\\]-fluoro-D-glucose positron emission tomography\u002Fcomputed tomography (FDG-PET\u002FCT) performed on day 30 post-infusion","day 30 post-infusion",[14,18],{"measure":15,"description":16,"timeFrame":17},"event-free survival (EFS)","was defined as the time from CAR T-cell infusion to disease progression, relapse, or death from any cause, whichever occurred first; patients alive without events were censored at the last follow-up","5 years",{"measure":19,"description":20,"timeFrame":17},"Overall survival","was calculated from the date of infusion to the date of death or last follow-up.",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","PROSPECTIVE","patients with relapse or refractiry LBCL treated in N.N. Alexandron National Cancer Center",[27],{"type":28,"name":29,"description":30,"armGroupLabels":21,"otherNames":21},"OTHER","CAR-T cell therapy","The academic CAR-T cell product presented in this study encodes the anti-CD19 CAR construct with the single-chain variable fragment (scFv) of an anti-CD19 monoclonal antibody (FMC63) conjugated with the CD8 hinge region, CD4-1BB transmembrane (TM), co-stimulatory domain, and the CD3ζ pro-activator signaling domain along with a truncated form of the epidermal growth factor receptor (EGFRt) cell surface protein as a co-expression marker and a safety switch mechanism.",[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Natalya Konoplya, PhD, MD, Professor","CONTACT","+375297723101","NKonoplya@mail.ru",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"NN Alexandrov National Cancer Centre of Belarus","RECRUITING","Lyasny","Minsk Oblast","223040","Belarus","BY",{"type":47,"coordinates":48},"Point",[49,50],27.6963,54.0072,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":54,"phoneExt":21,"email":36},"+375447500618",{"type":56,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100633294","real-world-practice-with-academic-anti-cd19-car-t-cell-therapy-in-relapserefractory-b-cell-lymphoma-100633294",false,"NCT07524816","Real World Practice With Academic Anti CD19 CAR-T Cell Therapy in Relapse\u002FRefractory B-cell Lymphoma","Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells","Inclusion Criteria:\n\n* age ≥18 years,\n* relapsed or refractory LBCL,\n* confirmed CD19 expression in tumor tissue,\n* prior exposure to at least one line of anti-tumor therapy\n\nExclusion Criteria:\n\n* pregnancy,\n* active hepatitis B or C infection, HIV infection,\n* naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%","ALL","18 Years","80 Years",{"count":68,"type":69},76,"ESTIMATED","3 Months","OBSERVATIONAL","Chimeric antigen receptor (CAR) T-cell therapy has been the standard of care for relapsed\u002Frefractory large B-cell lymphomas (R\u002FR LBCLs) since 2018. However, high cost of commercial products limits their application in real-world clinical practice. Academic approach to manufacturing CAR-T cell products can reduce the costs and improve availability and affordability of this therapy option. The aim of the present study is assess the efficacy and safety of the use of academic CAR-T cell products in r\u002Fr LBCL patients.This prospective observational study with r\u002Fr LBCL patients treated in the NN Alexandrov National Cancer Centre of Belarus. The CAR-T cell product was manufactured using lentiviral vector encoding anti-CD19 CAR.",[74],"Large B-Cell Lymphoma (LBCL)",[76,77,78,79],"academic CAR-T cell products","r\u002Fr large B-cell lymphomas","efficacy","safety","2026-04-09",{"date":82,"type":83},"2026-04-13","ACTUAL",{"date":85,"type":83},"2021-06-01",{"date":87,"type":69},"2029-01-01",{"name":5,"class":6},1]