[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629322":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":29,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":9,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":72,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"TICAROS Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TC011","EXPERIMENTAL","A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, TC011.",[13],"Drug: TC011",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Anti-CD19 Chimeric Antigen Receptor T cell",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Ah hyun Lim","CONTACT","82+1029985238","ah.lim@ticaros.com",{"name":27,"role":23,"phone":19,"phoneExt":19,"email":28},"admin","admin@ticaros.com",[30],{"facility":31,"status":32,"city":33,"state":33,"zip":34,"country":35,"countryCode":19,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Seoul National University Hospital","RECRUITING","Seoul","03080","South Korea",{"type":37,"coordinates":38},"Point",[39,40],126.9784,37.566,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":19,"phoneExt":19,"email":19},"Youngil Koh","PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100629322","phase-1-study-of-safety-and-efficacy-of-tc011-in-the-relapsedrefractory-large-b-cell-non-hodgkin-lymphoma-patients-100629322",false,"NCT07473167","Study of Safety and Efficacy of TC011 in the Relapsed\u002FRefractory Large B Cell Non-Hodgkin Lymphoma Patients","A Multi-center, Single Arm, Open-label Phase 1\u002F2 Clinical Trial to Evaluate Safety, and to Explore Efficacy of TC011(CD19 Targeted CAR-T) in the Relapsed\u002FRefractory Large B Cell Non-Hodgkin Lymphoma Patients","Inclusion Criteria:\n\nSubjects must meet all criteria including:\n\n* ≥19 years old, ECOG 0-2, life expectancy ≥12 weeks\n* Histologically confirmed B-cell lymphoma (WHO 2017)\n* Relapsed\u002Frefractory after ≥2 prior lines of systemic chemotherapy\n* ≥1 measurable lesion (longest diameter ≥1.5 cm)\n* Adequate organ, and pulmonary function\n* LVEF ≥40%\n* Able to undergo leukapheresis\n* For subjects of childbearing potential: agreement to use effective contraception for ≥6 months after TC011 infusion\n\nExclusion Criteria:\n\n* Unresolved ≥Grade 2 toxicities from prior therapy\n* Malignancy within 2 years except specified exceptions\n* Significant cardiac disease within 6 months\n* CNS involvement by lymphoma\n* Active HBV, HCV, HIV, syphilis\n* Rapidly progressing disease per investigator\n* Major surgery requiring general anesthesia within 4 weeks\n* Active or uncontrolled infection\n* Prior therapies such as anti-CD19 agents, adoptive T-cell therapy, gene therapy, allogeneic HSCT\n* Use of other investigational agents, immunosuppressants within protocol-specified windows\n* Pregnancy or breastfeeding\n* Hypersensitivity to study drug components\n* Leukapheresis-specific exclusions (recent chemotherapy, steroids, immunosuppressants)","ALL","19 Years",{"count":58,"type":59},98,"ESTIMATED","INTERVENTIONAL",[62,63],"PHASE1","PHASE2","This is a multi-center, phase I\u002FII study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.",[66,67,68,69,70,71],"Relapsed Large B-cell Lymphoma","Refractory Large B-cell Lymphoma","Diffuse Large B-cell Lymphoma (DLBCL)","High-grade B-cell Lymphoma (HGBL)","Transformed Follicular Lymphoma (TFL)","Primary Mediastinal Large B-cell Lymphoma (PMBCL)",[9,73,74,75],"CAR-T","Chimeric antigen receptor","CLIP","2026-03-10",{"date":78,"type":79},"2026-03-16","ACTUAL",{"date":81,"type":79},"2023-08-03",{"date":83,"type":59},"2028-03-10",{"name":5,"class":6},1]