[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ebv-associated-lymphoid-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ebv-associated-lymphoid-neoplasms":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"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":19,"type":20},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.",[24],"EBV Associated Lymphoid Neoplasms","NOT_YET_RECRUITING","2026-04-10",{"date":28,"type":29},"2026-04-13","ACTUAL",{"date":31,"type":20},"2026-04",{"date":33,"type":20},"2031-03",{"name":35,"class":36},"Ruijin Hospital","OTHER",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":37},"100616480","phase-1-gp350-car-t-for-relapserefractory-and-epstein-barr-virus-infection-associated-lymphoid-neoplasms-100616480","NCT07306156","GP350 CAR-T for Relapse\u002FRefractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms","GP350 CAR-T Cells for Relapse\u002FRefractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms, an Open-label, Single-arm Clinical Trial","ANXIN-02","Inclusion Criteria:\n\n1. Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038\u002Fs41375-022-01620-2);\n2. Disease Assessment:\n\n   1. Criteria for Relapsed\u002FRefractory lymphoid neoplasms: Meeting any one of the following three conditions: ① Failure to achieve at least a partial response (PR) per Lugano criteria after two cycles of standard first-line therapy; ② Disease progression within six months after achieving a response to first-line therapy, or progression after six months with no response to the original first-line or second-line regimen; ③ Relapse after hematopoietic stem cell transplantation.\n   2. Criteria for EBV Infection: Meeting any one of the following three conditions: ① Peripheral blood (plasma or whole blood) EBV DNA load ≥ 10³ copies\u002Fml by quantitative PCR; ②Tumor cell GP350 positivity (≥10% of tumor cells by immunohistochemistry or flow cytometry); ③ Serological detection of EBV antibodies indicating any of the following: positive anti-VCA-IgM; positive anti-EA-IgG; or simultaneous positivity for anti-VCA-IgM, anti-VCA-IgG, and anti-EBNA-IgG.\n   3. At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection.\n3. Performance Status: ECOG score 0-2 and expected survival ≥3 months;\n4. Age: 18-70 years, regardless of sex;\n5. Hematologic Criteria:\n\n   * Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL;\n   * Hemoglobin \\>60 g\u002FL;\n   * CD3+ T-cell count \\>0.5×10⁹\u002FL;\n   * Platelet count \\>30×10⁹\u002FL;\n6. Organ Function:\n\n   * Creatinine clearance ≥60 mL\u002Fmin;\n   * ALT\u002FAST ≤2× upper limit of normal (ULN);\n   * Total bilirubin ≤2× ULN;\n   * Left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion, and no clinically significant ECG abnormalities;\n   * Minimal or no pleural\u002Fascitic fluid;\n   * Oxygen saturation ≥95%;\n7. Contraception:\n\n   * Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception until the last follow-up;\n   * Male participants with fertile partners must agree to use effective contraception until the last follow-up;\n8. Informed Consent: Psychologically stable, capable of understanding the study's purpose and procedures, willing to participate voluntarily, and able to provide signed informed consent and comply with protocol requirements.\n\nExclusion Criteria:\n\n1. Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);\n2. Immunosuppression:\n\n   * History of acquired immunodeficiency syndrome (AIDS);\n   * Chronic use of immunosuppressants (including corticosteroids at doses equivalent to \\>15 mg\u002Fday of prednisone) for other conditions;\n3. Cardiac Dysfunction:\n\n   1. NYHA Class III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass grafting within the past 6 months;\n   3. Clinically significant ventricular arrhythmia or unexplained syncope;\n   4. History of severe non-ischemic cardiomyopathy;\n   5. Cardiac insufficiency (left ventricular ejection fraction \\\u003C45%) within 8 weeks prior to apheresis;\n4. Pregnancy\u002FContraception:\n\n   * Pregnant or lactating women;\n   * Participants (male or female) unwilling to use contraception;\n5. Hepatic\u002FRenal Impairment:\n\n   * AST\u002FALT \\>3× upper limit of normal (ULN);\n   * Total bilirubin \\>3× ULN;\n   * Creatinine clearance \\\u003C60 mL\u002Fmin;\n6. Allergies: History of severe hypersensitivity to any study drugs;\n7. Prior Stem Cell Transplant: Must have discontinued immunosuppressants for \\>6 weeks post-transplant with no signs of graft-versus-host disease (GVHD);\n8. Other Exclusionary Conditions: Any other condition deemed unsuitable by the investigator (e.g., coagulation disorders, hemolytic anemia, etc.).","18 Years","70 Years",{"count":49,"type":20},24,"INTERVENTIONAL",[52,53],"PHASE1","PHASE2","This is a Phase 1\u002FPhase 2 open-label, single-arm clinical study of GP350 CAR-T for Relapse\u002FRefractory and Epstein-Barr virus infection associated lymphoid neoplasms.\n\nEach participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T cells.\n\nEach participant will proceed through the following study procedures:\n\n* Screening\n* Enrollment\u002FLeukapheresis\n* Conditioning chemotherapy\n* CAR T treatment\n* Post-treatment assessment\n* Long-term follow-up",[24],[57,58,59,60,61],"LAHS","EBV","Lymphoma","Lymphoid neoplasms","CAR-T","RECRUITING","2025-12-24",{"date":65,"type":29},"2025-12-29",{"date":67,"type":29},"2025-11-10",{"date":69,"type":20},"2032-11-20",{"name":71,"class":36},"Zhimin Zhai"]