[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655280":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":47,"studyPopulation":40,"armGroups":48,"interventions":59,"overallOfficials":40,"centralContacts":69,"locations":75,"responsibleParty":96,"collaborators":40,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":40,"eligibilityCriteria":103,"healthyVolunteers":100,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":40,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":40,"overallStatus":116,"whyStopped":40,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Shanghai Junshi Bioscience Co., Ltd.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Overall survival (OS)","Overall survival (OS) evaluated based on 2014 Lugano criteria","up to approximately 24 months",[14,18,21,24,27,31,34,37],{"measure":15,"description":16,"timeFrame":17},"Objective response rate (ORR)","Objective response rate (ORR) based on 2014 Lugano criteria","up to approximately 12 months",{"measure":19,"description":20,"timeFrame":17},"complete response (CR)","The complete response rate (CR) evaluated based on 2014 Lugano criteria",{"measure":22,"description":23,"timeFrame":17},"Duration of response (DoR)","Duration of response (DoR) evaluated based on 2014 Lugano criteria",{"measure":25,"description":26,"timeFrame":17},"Duration of complete response (DoCR)","Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria",{"measure":28,"description":29,"timeFrame":30},"Adverse events (AE)","Incidence and severity of all adverse events (AE) that occurred during the clinical trial","up to approximately 15 months",{"measure":32,"description":33,"timeFrame":30},"PK","The serum drug concentration of JS203",{"measure":35,"description":36,"timeFrame":30},"ADA","The incidence and titer of the anti-drug antibody (ADA) of JS203",{"measure":38,"description":39,"timeFrame":30},"NAb","The incidence of neutralizing antibodies (NAb) of JS203 (if applicable)",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE","A Randomized Open-Label Multicenter Phase III Clinical Trial Comparing JS203 Combined With gemcitabine plus oxaliplatin (JS203-GemOx) Versus rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma",[49,54],{"label":50,"type":51,"description":40,"interventionNames":52},"JS203+Gemox","EXPERIMENTAL",[53],"Combination Product: JS203 in combination with gemcitabine and oxaliplatin",{"label":55,"type":56,"description":40,"interventionNames":57},"Rituximab+Gemox","ACTIVE_COMPARATOR",[58],"Combination Product: Rituximab in combination with gemcitabine and oxaliplatin",[60,65],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":40},"COMBINATION_PRODUCT","JS203 in combination with gemcitabine and oxaliplatin","gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days\u002Fcycle) Cycle 1 QW,Cycle 2 and therafter Q3W for up to 1 year",[50],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":40},"Rituximab in combination with gemcitabine and oxaliplatin","Rituximab and gemcitabine and oxaliplatin 8 cycles (Q3W)",[55],[70],{"name":71,"role":72,"phone":73,"phoneExt":40,"email":74},"Niannian Wang","CONTACT","13161547878","niannian_wang@junshipharma.com",[76],{"facility":77,"status":40,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Beijing Cancer Hospital","Beijing","Beijing Municipality","100142","China","CN",{"type":84,"coordinates":85},"Point",[86,87],116.39723,39.9075,{"lat":87,"lon":86},[90,94],{"name":91,"role":72,"phone":92,"phoneExt":40,"email":93},"Yuqin Song, Ph.D","010-88196118","SongYQ_VIP@163.com",{"name":91,"role":95,"phone":40,"phoneExt":40,"email":40},"PRINCIPAL_INVESTIGATOR",{"type":97,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100655280","phase-3-a-randomized-open-label-multicenter-phase-iii-clinical-study-of-js203-plus-chemotherapy-versus-rituximab-plus-chemotherapy-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100655280",false,"NCT07808827","A Randomized, Open-Label, Multicenter Phase III Clinical Study of JS203 Plus Chemotherapy Versus Rituximab Plus Chemotherapy in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria to be enrolled:\n* Age range: 18 to 75 years old (inclusive), both male and female are acceptable\n* ECOG: 0-1；\n* One of the confirmed histologies below with CD20-positivity:\n\nDLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL)\u002FMarginal Zone Lymphoma(MZL) \"Double-hit\" or \"triple-hit\" DLBCL , including de novo or histologically transformed from FL\u002FMZL FL Grade 3B T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n\n* At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment；\n* Acceptable organ function at screening；\n\nExclusion Criteria:\n\n* A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)；\n* Previously received CD20-CD3 bispecific antibody treatment；\n* Previous allogeneic hematopoietic stem cell transplantation；\n* Previous solid organ transplantation\n* History of autoimmune diseases\n* Patients with a history of macrophage activation syndrome (MAS)\u002F hemophagocytic lymphohistiocytosis (HLH)\n* Patients with a history of progressive multifocal leukoencephalopathy (PML)\n* A known or suspected history of CNS lymphoma (including primary or secondary)\n* There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage)","ALL","18 Years","75 Years",{"count":108,"type":109},282,"ESTIMATED","INTERVENTIONAL",[112],"PHASE3","This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (JS203-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R\u002FR DLBCL.",[115],"Diffuse Large B-Cell Lymphoma","NOT_YET_RECRUITING","2026-09-08",{"date":119,"type":120},"2026-09-09","ACTUAL",{"date":122,"type":109},"2026-09-24",{"date":124,"type":109},"2030-02-28",{"name":5,"class":6},1]