[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500801":3},{"organization":4,"outcomesModule":7,"designInfo":70,"detailedDescription":76,"studyPopulation":69,"armGroups":77,"interventions":84,"overallOfficials":92,"centralContacts":100,"locations":109,"responsibleParty":261,"collaborators":69,"id":263,"slug":69,"hasResults":264,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":264,"sex":270,"minAge":271,"maxAge":69,"enrollmentInfo":272,"targetDuration":69,"studyType":275,"phases":276,"briefSummary":279,"conditions":280,"keywords":69,"overallStatus":124,"whyStopped":69,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},{"fullName":5,"class":6},"Shanghai AbelZeta Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":69},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Phase 1b: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)","Incidence and severity of TEAEs , including dose limiting toxicities (DLTs)","Up to 90 days after C-CAR039 infusion",{"measure":14,"description":15,"timeFrame":16},"Phase 1b: Recommended Phase 2 Dose (R2PD)","Based on DLTs rates and overall safety profile","Up to 3 months after C-CAR039 infusion",{"measure":18,"description":19,"timeFrame":16},"Phase 2: Overall Response Rate (ORR) at 3 months","Best response rate at 3 months after C-CAR039 infusion, including partial response (PR) and complete response (CR)",[21,25,28,31,34,38,41,44,47,50,53,56,60,63,66],{"measure":22,"description":23,"timeFrame":24},"Phase 1b: Incidence and Severity of Adverse Events (AEs)","Incidence and severity of AEs","Up to 2 years after C-CAR039 infusion",{"measure":26,"description":27,"timeFrame":16},"Phase 1b: ORR at 3 months","Best response rate at 3 months after C-CAR039 infusion, including PR and CR",{"measure":29,"description":30,"timeFrame":24},"Phase 2: Incidence and Severity of Adverse Events (AEs)","Incidence and severity of any AEs",{"measure":32,"description":33,"timeFrame":24},"ORR","Best response, including PR and CR",{"measure":35,"description":36,"timeFrame":37},"ORR at 6 months","Best response rate at 6 months after C-CAR039 infusion, including PR and CR","Up to 6 months after C-CAR039 infusion",{"measure":39,"description":40,"timeFrame":24},"Duration of response (DOR)","The time from the first documented PR or CR to disease progression or death, whichever occurs first",{"measure":42,"description":43,"timeFrame":24},"Time to response (TTR)","The time from the date of C-CAR039 infusion to the first documented PR or CR",{"measure":45,"description":46,"timeFrame":24},"Progression-free survival (PFS)","The time from the date of C-CAR039 infusion to the date of first documented disease progression or death",{"measure":48,"description":49,"timeFrame":24},"Overall survival (OS)","The time from the date of C-CAR039 infusion to the date of death",{"measure":51,"description":52,"timeFrame":24},"Maximal plasma concentration (Cmax)","Maximal plasma concentration of C-CAR039 in peripheral blood",{"measure":54,"description":55,"timeFrame":24},"Time to reach the maximal plasma concentration (Tmax)","Time to reach the maximal plasma concentration of C-CAR039 in peripheral blood",{"measure":57,"description":58,"timeFrame":59},"Area under the curve within 28 days (AUC0-28d)","Area under the curve of C-CAR039 in peripheral blood within 28 days post infusion","Up to 28 days after C-CAR039 infusion",{"measure":61,"description":62,"timeFrame":24},"Time of last measurable observed concentration (Tlast)","Time of last measurable observed concentration of C-CAR039 in peripheral blood",{"measure":64,"description":65,"timeFrame":24},"The B cell percentage changes and CD19\u002FCD20 expression changes in blood","The B cell percentage changes and CD19\u002FCD20 expression changes in blood by flow cytometry assay before and after C-CAR039 infusion",{"measure":67,"description":68,"timeFrame":24},"Anti-drug (C-CAR039) antibody","Presence of serum anti-drug (C-CAR039) antibody",null,{"allocation":71,"interventionModel":72,"interventionModelDescription":69,"primaryPurpose":73,"observationalModel":69,"timePerspective":69,"maskingInfo":74},"NA","SINGLE_GROUP","TREATMENT",{"masking":75,"maskingDescription":69,"whoMasked":69},"NONE","The purpose of the study is to evaluate the safety and efficacy of Prizlon-cel. It includes two phases, Phase 1b and Phase 2. In Phase 1b study, RP2D will be determined. The selected dose will be further evaluated in the Phase 2 study. The study includes the following sequential procedures: Screening, Apheresis and CAR-T manufacturing, Baseline, Lymphodepletion, CAR-T infusion, DLT period (Phase 1b) and Follow-up Visit. Subjects will be followed for at least 2 years after Prizlon-cel infusion, with up to 15 years long-term follow-up on a separate study.",[78],{"label":79,"type":80,"description":81,"interventionNames":82},"Prizloncabtagene Autoleucel","EXPERIMENTAL","Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion.",[83],"Biological: Prizloncabtagene autoleucel",[85],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"BIOLOGICAL","Prizloncabtagene autoleucel","Prizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD19 and CD20 antigens",[79],[91],"C-CAR039",[93,97],{"name":94,"affiliation":95,"role":96},"Weili Zhao, M.D., PhD","Ruijin Hospital","PRINCIPAL_INVESTIGATOR",{"name":98,"affiliation":99,"role":96},"Lugui Qiu","Chinese Academy of Medical Sciences Hematology Hospital",[101,105],{"name":94,"role":102,"phone":103,"phoneExt":69,"email":104},"CONTACT","86-021-64370045","zwl_trial@163.com",{"name":106,"role":102,"phone":107,"phoneExt":69,"email":108},"Lugui Qiu, M.D., PhD","86-13821266636","Qiulg@ihcams.ac.cn",[110,122,131,139,150,161,169,180,191,202,213,223,234,242,253],{"facility":111,"status":112,"city":113,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":69},"Beijing Cancer Hospital","COMPLETED","Beijing","China","CN",{"type":117,"coordinates":118},"Point",[119,120],116.39723,39.9075,{"lat":120,"lon":119},{"facility":123,"status":124,"city":113,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":125,"geoPoint":127,"contacts":128},"Beijing GoBroad Hospital","RECRUITING",{"type":117,"coordinates":126},[119,120],{"lat":120,"lon":119},[129],{"name":130,"role":102,"phone":69,"phoneExt":69,"email":69},"Kai Hu, M.D.,PhD",{"facility":132,"status":124,"city":113,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":133,"geoPoint":135,"contacts":136},"Peking University Third Hospital",{"type":117,"coordinates":134},[119,120],{"lat":120,"lon":119},[137],{"name":138,"role":102,"phone":69,"phoneExt":69,"email":69},"Hongmei Jing, M.D.,PhD",{"facility":140,"status":124,"city":141,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Chongqing University Cancer Hospital","Chongqing",{"type":117,"coordinates":143},[144,145],106.55771,29.56026,{"lat":145,"lon":144},[148],{"name":149,"role":102,"phone":69,"phoneExt":69,"email":69},"Yao Liu, M.D.,PhD",{"facility":151,"status":124,"city":152,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Guangdong Provincial People's Hospital","Guangzhou",{"type":117,"coordinates":154},[155,156],113.25,23.11667,{"lat":156,"lon":155},[159],{"name":160,"role":102,"phone":69,"phoneExt":69,"email":69},"Wenyu Li, M.D.,PhD",{"facility":162,"status":124,"city":152,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":163,"geoPoint":165,"contacts":166},"Zhujiang Hospital of Southern Medical University",{"type":117,"coordinates":164},[155,156],{"lat":156,"lon":155},[167],{"name":168,"role":102,"phone":69,"phoneExt":69,"email":69},"Yuhua Li, M.D.,PhD",{"facility":170,"status":124,"city":171,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"The First Affiliated Hospital Zhejiang University School of Medicine","Hangzhou",{"type":117,"coordinates":173},[174,175],120.16142,30.29365,{"lat":175,"lon":174},[178],{"name":179,"role":102,"phone":69,"phoneExt":69,"email":69},"Jie Jin, M.D.,PhD",{"facility":181,"status":124,"city":182,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Cancer Hospital of Shandong First Medical University","Jinan",{"type":117,"coordinates":184},[185,186],116.99722,36.66833,{"lat":186,"lon":185},[189],{"name":190,"role":102,"phone":69,"phoneExt":69,"email":69},"Zengjun Li, M.D.,PhD",{"facility":192,"status":124,"city":193,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Jiangxi Cancer Hospital","Nanchang",{"type":117,"coordinates":195},[196,197],115.85306,28.68396,{"lat":197,"lon":196},[200],{"name":201,"role":102,"phone":69,"phoneExt":69,"email":69},"Wuping Li, M.D.,PhD",{"facility":203,"status":124,"city":204,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Jiangsu Province Hospital","Nanjing",{"type":117,"coordinates":206},[207,208],118.77778,32.06167,{"lat":208,"lon":207},[211],{"name":212,"role":102,"phone":69,"phoneExt":69,"email":69},"Lei Fan, M.D.,PhD",{"facility":214,"status":124,"city":215,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Ruijin Hospital, Shanghai Jiaotong University School of Medicine","Shanghai",{"type":117,"coordinates":217},[218,219],121.45806,31.22222,{"lat":219,"lon":218},[222],{"name":94,"role":102,"phone":69,"phoneExt":69,"email":69},{"facility":99,"status":124,"city":224,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Tianjin",{"type":117,"coordinates":226},[227,228],117.17667,39.14222,{"lat":228,"lon":227},[231,232],{"name":106,"role":102,"phone":69,"phoneExt":69,"email":69},{"name":233,"role":102,"phone":69,"phoneExt":69,"email":69},"Dehui Zou, M.D., PhD",{"facility":235,"status":124,"city":224,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"Tianjin Medical University Cancer Institute& Hospital",{"type":117,"coordinates":237},[227,228],{"lat":228,"lon":227},[240],{"name":241,"role":102,"phone":69,"phoneExt":69,"email":69},"Lanfang Li, M.D.,PhD",{"facility":243,"status":124,"city":244,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Henan Cancer Hospital","Zhengzhou",{"type":117,"coordinates":246},[247,248],113.64861,34.75778,{"lat":248,"lon":247},[251],{"name":252,"role":102,"phone":69,"phoneExt":69,"email":69},"Keshu Zhou, M.D.,PhD",{"facility":254,"status":124,"city":244,"state":69,"zip":69,"country":114,"countryCode":115,"cosmosGeoPoint":255,"geoPoint":257,"contacts":258},"The First Affiliated Hospital of Zhengzhou University",{"type":117,"coordinates":256},[247,248],{"lat":248,"lon":247},[259],{"name":260,"role":102,"phone":69,"phoneExt":69,"email":69},"Mingzhi Zhang, M.D.,PhD",{"type":262,"investigatorFullName":69,"investigatorTitle":69,"investigatorAffiliation":69,"oldNameTitle":69,"oldOrganization":69},"SPONSOR","100500801",false,"NCT05800977","A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","A Phase 1b\u002F2 Study of a Anti-CD19\u002FCD20 Bispecific CAR-T Therapy (C-CAR039\u002FPrizloncabtagene Autoleucel) in Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","ELEVATION","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms:\n\n  1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)\n  2. Primary mediastinal large B-cell lymphoma (PMBCL)\n  3. Transformed follicular lymphoma (tFL)\n  4. High-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements (HGBL-DH\u002FTH)\n  5. High-grade B-cell lymphoma, NOS (HGBL, NOS)\n  6. Follicular lymphoma grade 3B (FL3B)\n* Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT)\n* At least one measurable lesion per the Lugano 2014 Classification\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT within 12 weeks prior to apheresis\n* Suspected or confirmed central nervous system involvement\n* Stroke or convulsion history within 6 months of signing informed consent form (ICF)\n* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment\n* Uncontrolled active infection\n* Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive syphilis test\n* Severe heart, liver, renal or metabolism disease\n* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis\n* Prior CAR-T therapy","ALL","18 Years",{"count":273,"type":274},112,"ESTIMATED","INTERVENTIONAL",[277,278],"PHASE1","PHASE2","This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).",[281],"Relapsed\u002FRefractory Large B-Cell Lymphoma","2025-12-23",{"date":284,"type":285},"2025-12-31","ACTUAL",{"date":287,"type":285},"2023-02-22",{"date":289,"type":274},"2028-06-30",{"name":5,"class":6},15]