[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546510":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":19,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":19,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LUCAR-G39D cells product","EXPERIMENTAL","Each subject will be given a single-dose LUCAR-G39D cells infusion at each dose level.",[13],"Biological: LUCAR-G39D cells product",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Huilai Zhang","CONTACT","+86-18622221228","huilaizhangtz@163.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Kaiyang Ding","13966672170","dingkaiy@126.com",[31,47],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Oncology Department, The First Affiliated Hospital of USTC west district","RECRUITING","Hefei","Anhui","230000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],117.28083,31.86389,{"lat":43,"lon":42},[46],{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},{"facility":48,"status":33,"city":49,"state":19,"zip":50,"country":37,"countryCode":38,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Tianjin Cancer Hospital","Tianjin","300060",{"type":40,"coordinates":52},[53,54],117.17667,39.14222,{"lat":54,"lon":53},[57],{"name":58,"role":23,"phone":24,"phoneExt":19,"email":25},"Huilai Zhang, MD",{"type":60,"investigatorFullName":22,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Director of lymphoma department",[63],{"name":64,"class":65},"Nanjing Legend Biotech Co.","INDUSTRY","100546510","phase-1-targeting-cd19cd20-dual-targeted-cell-in-patients-with-relapsedrefractory-b-cell-non-hodgkin-lymphoma-100546510",false,"NCT06395870","Targeting CD19\u002FCD20 Dual-targeted Cell in Patients With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39D, a Dual-targeted Cell Preparation Targeting CD19\u002FCD20, in Patients With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.\n2. Aged 18-75 years (inclusive).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19\u002FCD20.\n5. At least one evaluable tumor lesion according to Lugano 2014 criteria.\n\nResponse to prior therapy is consistent with one of the following:\n\n1. Primary refractory.\n2. Relapsed or refractory after 2 or more lines of therapy.\n3. For LBCL, 3B FL. t-iNHL:\n\n   * Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;\n   * Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;\n\n     7\\. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria\n\n   Exclusion Criteria:\n\n   Subject eligible for this study must not meet any of the following criteria:\n\n   1\\. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).\n\n   6\\. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.\n\n   7\\. Pregnant or lactating women;","ALL","18 Years","75 Years",{"count":77,"type":78},33,"ESTIMATED","INTERVENTIONAL",[81],"PHASE1","A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19\u002FCD20, in patients with relapsed\u002Frefractory B-cell non-Hodgkin lymphoma.",[84,85],"B-Cell Non-Hodgkin Lymphoma-Recurrent","B-Cell Non-Hodgkin Lymphoma-Refractory","2024-11-04",{"date":88,"type":89},"2024-11-06","ACTUAL",{"date":91,"type":89},"2024-05-09",{"date":93,"type":78},"2028-06-30",{"name":5,"class":6},2]