[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651717":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":44,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":19,"overallStatus":68,"whyStopped":19,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral","EXPERIMENTAL","Each subject will receive a single dose of CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product infusion.",[13],"Biological: CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Prior to infusion of theCD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product, subjects may receive bridging therapy if needed.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Lei Fan","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","13813976136","fanlei3014@126.com",[30],{"facility":5,"status":19,"city":31,"state":32,"zip":33,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Nanjing","Jiangsu","China","CN",{"type":36,"coordinates":37},"Point",[38,39],118.77778,32.06167,{"lat":39,"lon":38},[42],{"name":43,"role":26,"phone":27,"phoneExt":19,"email":28},"Lei Fan, Doctor",{"type":23,"investigatorFullName":22,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Director of lymphoma center",[47],{"name":48,"class":49},"Nanjing Legend Biotech Co.","INDUSTRY","100651717","phase-1-cd19cd20-dual-target-in-vivo-car-t-lentiviral-product-in-the-treatment-of-relapsedrefractory-b-cell-malignancies-100651717",false,"NCT07763938","CD19\u002FCD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19\u002FCD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n1. Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.\n2. Age greater than or equal to 18.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. At least one measurable tumor lesion.\n5. Eligible subjects shall meet the criteria and qualification requirements of any one of the expansion cohorts as follows:\n\n   * Cohort 1: Relapsed or refractory large B-cell lymphoma patients who have received at least one line of systemic therapy and have not undergone CAR-T therapy;\n   * Cohort 2: High-risk large B-cell lymphoma patients in the first-line setting (who have completed 2 cycles of standard first-line systemic immunochemotherapy);\n   * Cohort 3: Relapsed or refractory mantle cell lymphoma patients treated with at least two lines of systemic therapy;\n   * Cohort 4: Exploratory cohort including relapsed or refractory indolent lymphoma and other B-cell malignancies.\n6. Life expectancy≥ 3 months\n7. Clinical laboratory values meet screening visit criteria\n8. Adequate organ function;\n\nExclusion Criteria:\n\nSubject eligible for this study must not meet any of the following criteria:\n\n1. Prior antitumor therapy with insufficient washout period ;\n2. Prior treatment with lentiviral vector-based gene therapies;\n3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).\n4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).\n5. Lactating women;","ALL","18 Years",{"count":60,"type":61},80,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies",[67],"Relapsed\u002FRefractory B-cell Malignancies","NOT_YET_RECRUITING","2026-08-09",{"date":71,"type":72},"2026-08-13","ACTUAL",{"date":74,"type":61},"2026-11-01",{"date":76,"type":61},"2032-12-30",{"name":5,"class":6},1]