[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633310":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":41,"armGroups":42,"interventions":47,"overallOfficials":37,"centralContacts":37,"locations":53,"responsibleParty":71,"collaborators":37,"id":75,"slug":37,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":37,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":37,"enrollmentInfo":83,"targetDuration":37,"studyType":86,"phases":37,"briefSummary":87,"conditions":88,"keywords":37,"overallStatus":90,"whyStopped":37,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Response Rate","The proportion of patients with complete and partial response after treatment.","Baseline up to 24 months after DC vaccines injection.",[14,17,20,24,28,31,35],{"measure":15,"description":16,"timeFrame":12},"Complete Response Rate","The proportion of patients with complete response after treatment.",{"measure":18,"description":19,"timeFrame":12},"Disease Control Rate","The proportion of patients with complete response, partial response, and stable disease after treatment.",{"measure":21,"description":22,"timeFrame":23},"Duration of Response","Duration of response is defined as the period from the first response (at least PR) to first occurrence of disease progression or relapse, or death from any cause, whichever occurred first.","From enrollment to study completion (up to approximately 24 months)",{"measure":25,"description":26,"timeFrame":27},"Progression-free survival","Progression-free survival is defined as the time from enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurred first.","Baseline up to data cut-off (up to 24 months)",{"measure":29,"description":30,"timeFrame":27},"Overall survival rate","Overall survival is defined as the time from enrollment to death from any cause.",{"measure":32,"description":33,"timeFrame":34},"Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0","Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.","From enrollment to study completion (up to 24 months)",{"measure":36,"description":37,"timeFrame":34},"Changes of EBV DNA load, lymphocytes and cytokines",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"COHORT","PROSPECTIVE","Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)",[43],{"label":44,"type":37,"description":37,"interventionNames":45},"KSD-101 therapy",[46],"Biological: Autologous dendritic cell vaccine",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":37},"BIOLOGICAL","Autologous dendritic cell vaccine","Subcutaneous injection, once every 2 weeks for 3-5 doses.",[44],[54],{"facility":41,"status":37,"city":55,"state":56,"zip":37,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Qionghai","Hainan","China","CN",{"type":60,"coordinates":61},"Point",[62,63],110.46417,19.2425,{"lat":63,"lon":62},[66],{"name":67,"role":68,"phone":69,"phoneExt":37,"email":70},"Wei-Li Zhao","CONTACT","0898-62629196","zwl_trial@163.com",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Professor and Director, Shanghai Institute of Hematology","100633310",false,"NCT07525024","KSD-101 in Patients With EBV-associated Hematological Malignancies","A Prospective, Single-arm, Observational Real-world Clinical Practice Study on the Efficacy and Safety of Dendritic Cell-based Vaccines (KSD-101) in Patients With EBV-associated Hematological Malignancies","Inclusion Criteria:\n\n* Patients with EBV-associated hematological malignancies who receive KSD-101 Vaccine Therapy (non-genetically modified) .\n\n  1. Patients aged 12 years or older on the date of signing the informed consent form.\n  2. Patients with a confirmed diagnosis of EBV-associated hematological malignancies who either: have failed standard treatment; or have voluntarily chosen KSD-101 as prophylactic \u002F anti-relapse therapy by the patient and\u002For their legal guardian.\n* The participant and\u002For their legal guardian voluntarily agrees to participate and has signed the informed consent form.\n\nExclusion Criteria:\n\n* Female patients who are pregnant (positive urine or serum pregnancy test), breastfeeding, or male\u002Ffemale patients planning to conceive within 1 year after enrollment.\n* Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the upper limit of normal; patients positive for anti-HCV antibody and peripheral blood HCV RNA; patients positive for anti-HIV antibody; or patients positive for syphilis-specific antibody.\n* Patients with central nervous system (CNS) involvement (e.g., cerebral edema requiring steroid intervention, or progressive brain metastasis).\n* Patients with uncontrolled infectious disease within 4 weeks prior to screening.\n* Patients with severe underlying diseases, including cardiovascular disease, respiratory disease, renal insufficiency, coagulation disorders, autoimmune disease, or immunodeficiency disease.\n* Patients who have received prophylactic live or attenuated live vaccines within 4 weeks prior to screening.\n* Patients who have participated in other clinical studies within 4 weeks prior to screening.\n* Patients with a history of severe drug allergy or penicillin allergy.\n* Patients with a history of drug abuse or addiction.\n* Any other conditions deemed inappropriate for study enrollment by the investigator team.","ALL","12 Years",{"count":84,"type":85},80,"ESTIMATED","OBSERVATIONAL","Epstein-Barr virus (EBV) is a double-stranded DNA virus belonging to the Gammaherpesvirinae subfamily of Herpesviridae. It primarily infects B cells and pharyngeal epithelial cells, and can also infect NK cells and T cells. EBV is closely associated with a variety of hematological malignancies, including EBV-positive diffuse large B-cell lymphoma (EBV+DLBCL), NK\u002FT-cell lymphoma (NKTCL), Hodgkin lymphoma (HL), Burkitt lymphoma (BL), EBV-positive nodal T-follicular helper cell lymphoma, angioimmunoblastic type (EBV+nTFHL-AI), and primary cutaneous T-cell lymphoma (CTCL). EBV-positive hematological malignancies are characterized by poor prognosis and limited therapeutic options, and there are currently no approved EBV-specific therapies. KSD-101 is a novel dendritic cell vaccine loaded with EBV-associated tumor-like composite antigens, which possesses strong antigen-presenting capacity and can initiate EBV-specific T-cell immunity. This study aims to investigate the real-world clinical efficacy and safety of KSD-101, providing an important reference for optimizing its clinical application, as well as theoretical support for the further development of novel therapeutic strategies.",[89],"EBV Associated Lymphoid Neoplasms","NOT_YET_RECRUITING","2026-04-10",{"date":93,"type":94},"2026-04-13","ACTUAL",{"date":96,"type":85},"2026-04",{"date":98,"type":85},"2031-03",{"name":5,"class":6},1]