[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ebv-associated-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ebv-associated-tumors":25},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100619839","early-phase-1-application-of-mrna-immunotherapy-technology-in-eb-virus-related-diseases-100619839",false,"NCT07349836","Application of mRNA Immunotherapy Technology in EB Virus Related Diseases","Inclusion Criteria:\n\n* 1\\. Male or female patients aged ≥ 18 years old;\n* 2\\. Diagnosed with EBV related diseases through histology or cytology, including but not limited to nasopharyngeal carcinoma, gastric cancer, lymphoma, EBV disease after HSCT etc;\n* 3\\. ECOG physical condition score: 0-2 points;\n* 4\\. Expected survival period ≥ 3 months;\n* 5\\. The main organ functions well, that is, the relevant examination indicators meet the requirements;\n* 6\\. The subject has no pregnancy plan during the treatment period and agrees to voluntarily take effective contraceptive measures during the trial period and within 4 months of stopping treatment, and the pregnancy of women of childbearing age is negative;\n* 7\\. Able to understand and voluntarily sign a written informed consent form before the experiment;\n* 8\\. Able to communicate well with researchers and complete experiments according to the protocol.\n\nExclusion Criteria:\n\n* 1\\. The patient has a history of other tumors in the past, except for the cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, gastrointestinal intramucosal carcinoma and other malignant tumors that the researchers think can be included;\n* 2\\. Central nervous system (CNS) tumors or CNS metastases;\n* 3\\. Chest fluid, ascites, and pericardial effusion that require drainage due to clinical symptoms; Hepatic encephalopathy, hepatorenal syndrome, or Child Pugh B or more severe cirrhosis;\n* 4\\. Known to have invasive NK cell leukemia or NK lymphoblastic leukemia\u002Flymphoma; Or accompanied by hemophilic cell syndrome;\n* 5\\. There are any uncontrollable clinical or mental illnesses or other major illnesses that, according to the researcher's assessment, may hinder the provision of informed consent, interfere with the interpretation of the trial results, pose risks to the subjects participating in this trial, or otherwise affect the achievement of the trial objectives;\n* 6\\. Allergic to the experimental drug (including any excipients). Previous history of severe allergies to any medication, food, or vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;\n* 7\\. The most recent anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local regional therapy) is less than 4 weeks after the first dose or within 5 half lives of the drug (whichever is shorter), or palliative radiotherapy is less than 2 weeks after the first dose; Patients with adverse reactions related to anti-tumor therapy (excluding hair loss) that have not recovered to NCI CTCAE ≤ 1 or inclusion criteria after previous anti-tumor therapy;\n* 8\\. Subjects who receive systemic therapy with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) or other immunosuppressive agents within 14 days prior to their first administration. In the absence of active autoimmune diseases, inhalation or topical use of steroids and adrenal hormone replacement with a dose ≤ 10 mg\u002Fday of prednisone efficacy dose is allowed;\n* 9\\. Within 6 months prior to the first administration, have received mRNA vaccines or lipid nanoparticles (LNP) equivalent nanoparticles for drug delivery;\n* 10\\. Having undergone major surgery within the 4 weeks prior to screening (excluding minor surgeries such as catheter insertion or biopsy surgery as required by the protocol), or the impact of surgery or trauma has been eliminated for less than 14 days prior to enrollment;\n* 11\\. Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcohol or drug abuse;\n* 12\\. Known active infections such as hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), syphilis, etc.:\n* 13\\. The researchers believe that there are any other factors that are not suitable for the subjects to enter this trial.","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","EB virus is associated with various epithelial and lymphoid derived tumors, such as Burkitt lymphoma, Hodgkin lymphoma, epithelial derived nasopharyngeal carcinoma, and some gastric cancers. In EBV related tumors, epithelial tumors account for over 80%, with the majority being nasopharyngeal carcinoma and EVB related gastric cancer. Among lymphomas, NK\u002FT-cell lymphoma is the lymphoma most closely associated with EBV infection, accounting for approximately 6%. In the world, the incidence rate of NK\u002FT lymphoma in China is the highest, and it is a malignant lymphoma with rapid development and strong invasion.\n\nmRNA immunotherapy is a promising novel anti-tumor treatment method. Previous basic research and clinical practice have shown that immune drugs prepared using antigen-presenting cells loaded with tumor antigens, CAR-T cells, etc. can produce objective clinical therapeutic effects. Compared with traditional immune drugs, mRNA immune drugs have unique advantages in the field of tumor immunotherapy. They can express and present antigens for a long time, thereby stimulating stronger immune responses and producing cytotoxic T cells (CTLs) that specifically recognize EB virus antigens, exerting anti-tumor effects.\n\nPrevious studies have preliminarily confirmed that the mRNA immunotherapy monotherapy has good safety and tolerability in various tumor populations. Considering that most EBV positive tumor patients have limited treatment options, and that PD-1\u002FL1 inhibitors have shown excellent anti-tumor efficacy in the treatment of various malignant tumors, research on mRNA vaccine monotherapy and its combination with immune checkpoint inhibitors is being conducted to provide more treatment options for patients with EB virus related tumors.",[25],"EBV-associated Tumors","NOT_YET_RECRUITING","2026-01-15",{"date":29,"type":30},"2026-01-20","ACTUAL",{"date":32,"type":19},"2026-01-10",{"date":34,"type":19},"2028-12-31",{"name":36,"class":37},"Xinqiao Hospital of Chongqing","OTHER",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":20,"phases":45,"briefSummary":47,"conditions":48,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":4},"100600749","the-application-of-mrna-immunotherapy-technology-in-refractory-malignancies-associated-with-epstein-barr-virus-ebv-100600749","NCT07101536","The Application of mRNA Immunotherapy Technology in Refractory Malignancies Associated With Epstein-Barr Virus (EBV)","Inclusion Criteria:\n\nPhase 1: Monotherapy Study of mRNA Vaccine\n\n* Male or female patients aged ≥18 years;\n* Patients with advanced Epstein-Barr virus (EBV)-positive tumors (e.g., nasopharyngeal carcinoma, NK\u002FT-cell lymphoma, or gastric cancer) who have failed at least two lines of standard therapy;\n* Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2;\n* Estimated survival ≥3 months;\n* Adequate major organ function;\n* Additional inclusion criteria may be supplemented.\n\nPhase 2: Combination Therapy Study of mRNA Vaccine\n\n* Male or female patients aged ≥18 years at screening;\n* Histopathologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) not amenable to local therapy, with documented failure of at least one prior platinum-containing chemotherapy regimen and PD-1\u002FL1 immunotherapy;\n* Positive for Epstein-Barr virus-encoded RNA (EBER) in tumor tissue;\n* At least one measurable lesion per RECIST v1.1 criteria;\n* Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2;\n* Additional inclusion criteria may be supplemented.\n\nExclusion Criteria:\n\nPhase 1: Monotherapy Study of mRNA Vaccine\n\n* Participation in another clinical drug trial within the past 4 weeks;\n* History of other malignancies, unless it is cervical carcinoma in situ, treated cutaneous squamous cell carcinoma or urothelial tumors, or other malignancies that have undergone curative treatment (at least 5 years prior to enrollment);\n* Uncontrolled cardiac symptoms or diseases;\n* Female subjects who are pregnant or breastfeeding;\n* Active tuberculosis, bacterial or fungal infections; active HIV infection, active HBV infection, or HCV infection;\n* Additional exclusion criteria may be supplemented.\n\nPhase 2: Combination Therapy Study of mRNA Vaccine\n\n* History of other primary malignancies within 3 years prior to the first dose, excluding adequately treated tumors with no evidence of recurrence for at least 2 years;\n* Known clinically significant uncontrolled cardiac symptoms or diseases;\n* Presence of central nervous system disorders (e.g., epilepsy, severe cerebrovascular stenosis), or history of cerebrovascular accident (e.g., stroke) or other cerebrovascular events within 6 months prior to screening, or other conditions (including psychiatric disorders) with overt neurological symptoms;\n* Known history of interstitial pneumonia or high suspicion of interstitial pneumonia; or presence of pulmonary abnormalities that may interfere with the detection or management of suspected drug-related pulmonary toxicity during the trial;\n* Any active autoimmune disease or history of autoimmune diseases;\n* Additional exclusion criteria may be supplemented.",{"count":18,"type":19},[46],"NA","Epstein-Barr virus (EBV) is an important tumor-associated virus. In 1997, the World Health Organization (WHO) officially classified EBV as a Group 1 carcinogen, as it is implicated in the pathogenesis of various epithelial malignancies and multiple types of lymphomas. Epithelial malignancies associated with EBV infection include nasopharyngeal carcinoma (NPC), gastric cancer, colorectal cancer, breast cancer, cervical cancer, prostate cancer, and oral cancer, among others. Currently, optimal therapeutic strategies for EBV-associated tumors remain lacking, particularly in patients with recurrent, metastatic, or refractory disease. Furthermore, although EBV infection plays a significant role in the development and progression of EBV-positive tumors and may influence patient prognosis, there are currently no precision therapeutic approaches specifically targeting EBV-positive lymphomas. Thus, treatment options for this patient population warrant further attention.\n\nEBV mRNA vaccine is a therapeutic vaccine based on messenger RNA (mRNA) targeting antigens related to EBV. This clinical trial aims to evaluate the safety, tolerability, immunogenicity, and preliminary antitumor activity of EBV mRNA vaccine in patients with advanced EBV-positive malignant tumors, thereby providing a scientific basis for subsequent clinical development.",[25],"2025-07-27",{"date":51,"type":30},"2025-08-03",{"date":53,"type":19},"2025-08-01",{"date":55,"type":19},"2027-12-31",{"name":57,"class":37},"West China Hospital"]