[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593105":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":51,"studyPopulation":44,"armGroups":52,"interventions":59,"overallOfficials":44,"centralContacts":65,"locations":72,"responsibleParty":173,"collaborators":176,"id":180,"slug":44,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":44,"eligibilityCriteria":185,"healthyVolunteers":181,"sex":186,"minAge":187,"maxAge":44,"enrollmentInfo":188,"targetDuration":44,"studyType":191,"phases":192,"briefSummary":194,"conditions":195,"keywords":44,"overallStatus":75,"whyStopped":44,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":44},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)","An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.","Through study completion, an average of 2 years afterCD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)",{"measure":14,"description":15,"timeFrame":16},"Pharmacokinetics in peripheral blood","CAR positive T cells and CAR transgene percentage of in peripheral blood after CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral infusion.","Through study completion, an average of 2 years after CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)",{"measure":18,"description":19,"timeFrame":16},"Pharmacokinetics in bone marrow","CAR positive T cells and CAR transgene percentage of in bone marrow after CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral infusion.",{"measure":21,"description":22,"timeFrame":23},"The recommended Phase II dose (RP2D) for this cell therapy","RP2D established through 3+3 design and the DLTs occurring following CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral infusion","30 days after CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral infusion",[25,29,32,35,38,41],{"measure":26,"description":27,"timeFrame":28},"Overall Response Rate (ORR)","Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral cell infusion","Through study completion, an average 2 years after CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)",{"measure":30,"description":31,"timeFrame":28},"Progression-free survival (PFS)","Progression Free Survival (PFS) is defined as the time from the date of first infusion of the CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral to the first documented disease progression or death, whichever occurs first",{"measure":33,"description":34,"timeFrame":28},"Overall Survival (OS)","Overall Survival (OS) is defined as the time from the date of first infusion of CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral to death of the subject",{"measure":36,"description":37,"timeFrame":28},"Time to Response (TTR)","Time to Response (TTR) is defined as the time from the date of first infusion of CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral to the date of the first response evaluation of the subject who has met all criteria for CR or PR",{"measure":39,"description":40,"timeFrame":28},"Duration of Response (DoR)","Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders",{"measure":42,"description":43,"timeFrame":28},"Immunogenicity assessment of CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral infusion","The incidence of Anti- CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral antibody in patients who received CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral infusion",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"NA","SINGLE_GROUP","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE","This is an open-label, dose-escalation\u002Fdose extension study to assess the safety, tolerability, and efficacy of CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product in the patient ≥ 18 years of age with relapsed or refractory B-cell Malignancies. Subjects who meet the eligibility criteria will receive a single dose of CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product. The study will include the following sequential phases: screening, bridging therapy (if needed), treatment, and follow-up.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral","EXPERIMENTAL","Each subject will be given a single-dose CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product infusion at each dose level.",[58],"Biological: CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product",[60],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":44},"BIOLOGICAL","CD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product","Prior to infusion of theCD19\u002FCD20 Dual-Target in vivo CAR-T Lentiviral product, subjects will receive bridging therapy if needed.",[54],[66],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"FAN Lei","CONTACT","13813976136","+86","fanlei3014@126.com",[73,94,110,126,143,159],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"The First Affiliated Hospital of USTC west district","RECRUITING","Hefei","Anhui","230000","China","CN",{"type":82,"coordinates":83},"Point",[84,85],117.28083,31.86389,{"lat":85,"lon":84},[88,92],{"name":89,"role":68,"phone":90,"phoneExt":70,"email":91},"Kaiyang DING","13966672170","dingkaiy@126.com",{"name":89,"role":93,"phone":44,"phoneExt":44,"email":44},"PRINCIPAL_INVESTIGATOR",{"facility":95,"status":75,"city":96,"state":97,"zip":98,"country":79,"countryCode":80,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Beijing Gobroad Boren Hospita","Beijing","Beijing Municipality","102206",{"type":82,"coordinates":100},[101,102],116.39723,39.9075,{"lat":102,"lon":101},[105,109],{"name":106,"role":68,"phone":107,"phoneExt":70,"email":108},"Yajing ZHANG","18601333856","23975701@qq.com",{"name":106,"role":93,"phone":44,"phoneExt":44,"email":44},{"facility":111,"status":75,"city":112,"state":113,"zip":114,"country":79,"countryCode":80,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"The Fourth Hospital of Hebei Medical University","Shijiazhuang","Hebei","050000",{"type":82,"coordinates":116},[117,118],114.47861,38.04139,{"lat":118,"lon":117},[121,125],{"name":122,"role":68,"phone":123,"phoneExt":70,"email":124},"Haisheng LIU","13933078299","liuhs78299@163.com",{"name":122,"role":93,"phone":44,"phoneExt":44,"email":44},{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":79,"countryCode":80,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"The First Affiliated Hospital of ZHENGZHOU University","NOT_YET_RECRUITING","Zhengzhou","Henan","450000",{"type":82,"coordinates":133},[134,135],113.64861,34.75778,{"lat":135,"lon":134},[138,142],{"name":139,"role":68,"phone":140,"phoneExt":70,"email":141},"Yi Zhang","15138928971","yizhang001@163.com",{"name":139,"role":93,"phone":44,"phoneExt":44,"email":44},{"facility":144,"status":75,"city":145,"state":146,"zip":147,"country":79,"countryCode":80,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Union Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","Hubei","430000",{"type":82,"coordinates":149},[150,151],114.26667,30.58333,{"lat":151,"lon":150},[154,158],{"name":155,"role":68,"phone":156,"phoneExt":70,"email":157},"Heng MEI","13886160811","mayheng@126.com",{"name":155,"role":93,"phone":44,"phoneExt":44,"email":44},{"facility":5,"status":75,"city":160,"state":161,"zip":162,"country":79,"countryCode":80,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Nanjing","Jiangsu","210029",{"type":82,"coordinates":164},[165,166],118.77778,32.06167,{"lat":166,"lon":165},[169,172],{"name":170,"role":68,"phone":69,"phoneExt":171,"email":71},"Lei FAN","+186",{"name":170,"role":93,"phone":44,"phoneExt":44,"email":44},{"type":93,"investigatorFullName":174,"investigatorTitle":175,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Lei Fan","Director of lymphoma center",[177],{"name":178,"class":179},"Nanjing Legend Biotech Co.","INDUSTRY","100593105",false,"NCT07002112","The CD19\u002FCD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed\u002FRefractory B-cell Malignancies","A Phase I 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 evaluable tumor lesion.\n5. Relapsed and\u002For refractory NHL , and relapsed and\u002For refractory CLL with treatment indications\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":189,"type":190},30,"ESTIMATED","INTERVENTIONAL",[193],"PHASE1","A Phase I 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.",[196],"Relapsed\u002FRefractory B-cell Malignancies","2026-05-11",{"date":199,"type":200},"2026-05-14","ACTUAL",{"date":202,"type":200},"2025-05-23",{"date":204,"type":190},"2029-06-30",{"name":5,"class":6},6]