[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633310":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":10,"locations":19,"responsibleParty":38,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":10,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":10,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"KSD-101 therapy",null,[12],"Biological: Autologous dendritic cell vaccine",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"BIOLOGICAL","Autologous dendritic cell vaccine","Subcutaneous injection, once every 2 weeks for 3-5 doses.",[9],[20],{"facility":21,"status":10,"city":22,"state":23,"zip":10,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)","Qionghai","Hainan","China","CN",{"type":27,"coordinates":28},"Point",[29,30],110.46417,19.2425,{"lat":30,"lon":29},[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Wei-Li Zhao","CONTACT","0898-62629196","zwl_trial@163.com",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Professor and Director, Shanghai Institute of Hematology","100633310","ksd-101-in-patients-with-ebv-associated-hematological-malignancies-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":52,"type":53},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.",[57],"EBV Associated Lymphoid Neoplasms","NOT_YET_RECRUITING","2026-04-10",{"date":61,"type":62},"2026-04-13","ACTUAL",{"date":64,"type":53},"2026-04",{"date":66,"type":53},"2031-03",{"name":5,"class":6},1]