[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ebv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ebv-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,57,90,117,141,168,193,217],{"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":22,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100644480","phase-1-evaluation-of-the-safety-and-efficacy-of-lb-dtk-mv-in-patients-diagnosed-with-antiviral-resistant-cmv-bkv-or-ebv-infection-or-associated-diseases-following-anticancer-therapy-or-allogeneic-hematopoietic-stem-cell-transplantation-100644480",false,"NCT07670468","Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.","A Single-Center, Open-Label, Phase 1\u002F2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n1. Patients aged 19 years or older who have undergone myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation using bone marrow, single or double umbilical cord blood, or peripheral blood stem cells (PBSCs). Or patients who have undergone any of the following anticancer treatments:\n\n   * CAR-T: Kymriah, Yescarta\n   * Bispecific Antibody: Glofitamab, Mosunetuzumab, Teclistamab, Elranatamab, etc\n2. Patients diagnosed with single or multiple, antiviral-resistant CMV, BKV, and\u002For EBV despite receiving standard treatment.\n3. Patients who are able to reduce their steroid dosage to 0.5mg\u002Fkg\u002Fday of Prednisolone (or an equivalent dose) or less.\n4. Patients with a hemoglobin level ≥8.0g\u002FdL.\n5. Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5x10\\^3\u002FμL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.\n6. Patients with peripheral oxygen saturation (SpO2) ≥90% on room air.\n7. Patients who have at least one MHC class I HLA allele that matches the investigational product.\n8. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.\n9. Female subjects or male subjects with female partners who agree to use the following contraceptive methods during the duration of this clinical trial and who meet the following criteria:\n\n   * Female participants or male participants with female partners who are postmenopausal (diagnosed with non-therapy-induced amenorrhea for 12 months or more or menopause)\n   * Female subjects or the female partners of male subjects who are surgically sterile (i.e., lacking ovaries and\u002For a uterus)\n   * Individuals who have agreed to strict abstinence during the clinical trial period \\[For female participants, intermittent abstinence (e.g., withdrawal during ovulation, the basal body temperature method, or withdrawal after ovulation) does not constitute agreement to abstinence\\]\n   * If the female subject or the female partner of a male subject is a woman of childbearing potential (WOCBP) who has not undergone sterilization, those who meet the following criteria:\n\n     * Hormonal contraceptives (implant, patch, oral)\n     * Intrauterine devices\n     * Dual barrier method (simultaneous use of the following two contraceptive methods: male condoms, female condoms, cervical caps, contraceptive diaphragms, contraceptive sponges)\n10. Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions.\n11. Individuals deemed suitable as trial subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).\n\nExclusion Criteria:\n\n1. Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.\n2. Individuals who meet any of the following criteria at the time of screening:\n\n   * Uncontrolled hypertension\n\n     * Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.\n   * Uncontrolled diabetes: Severe diabetes is defined as follows:\n\n     * Severe hyperglycemia with HbA1C ≥ 10.0%\n     * Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks.\n     * Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose \\\u003C54 mg\u002FdL) accompanied by seizures and loss of consciousness.\n   * Other viral infections \\[Ex. Human Immunodeficiency Virus(HIV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV)\\]. However, patients who are tested negative for HBsAg and positive for anti-HBcAb are not subject to this exclusion criterion.\n   * Tuberculosis\n   * Syphilis\n   * Moderate or severe liver damage \\[Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN)\\]\n   * Chronic kidney disease \\[eGFR \\\u003C 30mL\u002Fmin\u002F1.73m\\^2\\]\n   * Patients with other uncontrolled infections. However, the following cases are considered controlled infections and do not meet the exclusion criteria:\n\n     * Bacterial infection. Patients must be undergoing definitive antibiotic treatment for the infection and must have shown no signs of progression of the infection for 72 hours prior to enrollment in this clinical trial.\n     * Fungal infection. The patient must be receiving systemic antifungal therapy and must have shown no signs of infection progression for 1 week prior to enrollment in this clinical trial.\n3. Patients who have undergone allogeneic hematopoietic stem cell transplantation within 28 days prior to the scheduled first dose, or who have received donor lymphocyte infusion (DLI) within 28 days prior to enrollment in this clinical trial.\n4. Patients with active acute graft-versus-host disease (GvHD) of grade 2 or higher.\n5. Patients requiring urgent anticancer therapy due to rapid tumor progression.\n6. Patients with a history of substance abuse within 24 weeks prior to administration of the investigational drug, or patients suspected of taking drugs of concern based on medical history and physical examination.\n7. Patients requiring vasopressors.\n8. Patients who have previously shown hypersensitivity to T-cell therapy.\n9. Patients with a history of autoimmune disease.\n10. Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants.\n11. Patients who have received another virus-specific T cell product within 28 days prior to administration of the investigational drug.\n12. Patients with a life expectancy of less than 24 hours at the time of the screening visit.\n13. Patients aged under 19.\n14. Patients deemed ineligible for participation in this clinical trial by the investigator.","ALL","19 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after anticancer therapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:\n\n* What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting toxicity?\n* Does the number of CMV, BKV, or EBV virus viral load decrease within 7 or 14 days after the second infusion of LB-DTK-MV?\n* Do treatment emergent adverse events occur after the second infusion?\n\nParticipants will:\n\n* Receive a single intravenous infusion of LB-DTK-MV during the baseline visit (low dose: 1x10\\^7\u002Fm\\^2; high dose: 2x10\\^7\u002Fm\\^2).\n* Receive the second infusion of LB-DTK-MV intravenously at the same dose 14 days after the first infusion.\n* Attend weekly follow-up visits at the clinic for 6 months after the first dose.",[27,28,29],"BKV Infection","EBV Infection","CMV Infection",[31,32,33,34,35,36,37,38,39,40,41,42,43],"CMV","EBV","BKV","Multi-virus","CMV-associated diseases","EBV-associated diseases","BKV-associated diseases","Allogeneic Hematopoietic Stem Cell Transplantation","Virus-specific T cells","Infections","Virus Diseases","Antiviral-resistant infection","Anticancer therapy","RECRUITING","2026-06-19",{"date":47,"type":48},"2026-06-26","ACTUAL",{"date":50,"type":48},"2025-12-04",{"date":52,"type":20},"2027-06-04",{"name":54,"class":55},"LucasBio","INDUSTRY",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":56},"100298003","phase-1-antigen-specific-cytotoxic-t-cells-in-the-treatment-of-opportunistic-infections-100298003","NCT03159364","Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections","Phase I\u002FII Multicenter Trial of Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections","Inclusion Criteria:\n\nSubjects with or without hematopoietic stem cell transplantation \u002F organ transplant recipients need to meet the following conditions:\n\n* Evidence of CMV, EBV, ADV, BKV or known pathogen infection (viral DNA, immunohistochemical cytology positive); contraindications or invalid to anti-microbial drugs.\n* Subjects with virus DNA increased in the 2 consecutive peripheral blood samples (≥ 1000 genomic copies\u002Fml blood) at least 24 hours apart.\n* Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 0.5x109 \u002F L, platelet (PLT) ≥ 20x109 \u002F L.\n* Patients with pahogen disease (organ\u002F tissue infiltration) symptoms, fever, diarrhea, or lymphadenopathy, regardless of the level of peripheral blood virus DNA, and confirmed by the presence of viral DNA or microbial antigens within body fluid or biopsy.\n* The subject \u002F guardian has signed a written consent form before any trial begins.\n\nProper renal and hepatic functions (ULN denotes \"upper limit of normal range\"):\n\n* Creatinine ≤ 2\\*ULN.\n* Bilirubin ≤ 2\\*ULN.\n* SGOT ≤ 3\\*ULN.\n* SGPT≤ 3\\*ULN.\n\nIf CTL is not from the patient's own, then the provider of CTLs needs to meet the following criteria:\n\n* Did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.\n* White blood cells ≥ 3,500 \u002F μl, lymphocytes ≥ 750 \u002F μl.\n* Obtain a signed informed consent from the patient and \u002F or the guardian or the donor of the BMT recipient.\n* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test is negative.\n* Physical examination in line with the standard of healthy blood donors.\n\nExclusion Criteria:\n\n* Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), or HTLV (HTLV antibody positive).\n* GVHD (graft-versus-host disease) performance score at II-IV.\n* Subject is albumin-intolerant.\n* Subject with life expectancy less than 4 weeks.\n* Subject participated in other investigational somatic cell therapies within past 30 days.\n* Subject with positive pregnancy test result.","6 Months","80 Years",{"count":67,"type":20},100,[23,24],"Epstein Barr Virus (EBV) or Cytomegalovirus (CMV) infection results in significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients. HSCT patients often face opportunistic infections due to the immunosuppressive state during transplantation. Antimicrobial drugs are usually used for prophylactic purposes and for treatment after early detectable infections. Unfortunately, some patients develop resistance to such drug treatment. In addition to HSCT patient, immune compromised patient may also be victim to opportunistic infections. Many infections can be effectively managed by functional immune recovery. In this study, the safety and efficacy of microbial-specific cytotoxic T lymphocytes (CTLs) will be investigated.",[71,28,29,72,27,73,74],"Pathogen Infection","Adenovirus Infection","Fungus Infection","Tuberculosis",[76,77,78,79],"CTL","Virus CTL","Fungus CTL","TB CTL","2026-06-18",{"date":82,"type":48},"2026-06-22",{"date":84,"type":48},"2026-06-01",{"date":86,"type":20},"2030-12-31",{"name":88,"class":89},"Shenzhen Geno-Immune Medical Institute","OTHER",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":56},"100615587","is-valacyclovir-non-inferior-to-valganciclovir-as-cmv-and-ebv-prophylaxis-in-kidney-transplant-recipients-a-single-center-prospective-randomized-pilot-study-100615587","NCT07294547","Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study","Non-Inferiority Assessment of Valacyclovir Versus Valganciclovir as Prophylaxis Against CMV and EBV Viremia in Kidney Transplant Recipients: A Single-Center Prospective Randomized Pilot Study.","Inclusion Criteria:\n\n* Age at least 3 years of age\n* Patients who are about to receive or just received kidney transplantation within the past 2 weeks before the date of screening.\n* Will be receiving prophylactic antiviral therapy against CMV and\u002For EBV per discretion of transplant surgeon\n* No active CMV or EBV viremia (as defined by detectable viral load PCR) at the time of screening.\n* Ability and willingness of the patient (or parent\u002Flegal guardian for minors) to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Severe co-morbidities that would preclude safe participation as judged by the transplant surgeon\n* Pregnancy (valganciclovir is likely teratogenic)\n* Known allergy to both valacyclovir and valganciclovir","3 Years",{"count":99,"type":20},80,[101],"NA","Opportunistic CMV viremia (primary infection or reactivation) is usually managed by taking prophylactic medication for both adult and pediatric kidney transplant patients. Most hospitals prescribe valganciclovir for this purpose but valacyclovir has also been used. The most unfavorable side effect of valganciclovir is bone marrow suppression which can be troublesome for kidney transplant patients who are already immunosuppressed. We aim to assess the non-inferiority of valacyclovir compared with valganciclovir in this study.",[104,28,105],"Kidney Transplantation, Cytomegalovirus Infections","Antiviral Prophylaxis",[107],"Non-Inferiority Assessment of Valacyclovir versus Valganciclovir as Prophylaxis Against CMV and EBV Viremia in Kidney Transplant Recipients","2025-12-08",{"date":110,"type":48},"2025-12-19",{"date":112,"type":48},"2025-11-27",{"date":114,"type":20},"2030-12",{"name":116,"class":89},"National Taiwan University Hospital",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100613025","phase-2-zuberitamab-for-ebv-infection-post-allo-hsct-100613025","NCT07261215","Zuberitamab for EBV Infection Post-Allo-HSCT","A Study on the Efficacy and Safety of Zuberitamab as First-Line Preemptive Therapy for EBV Infection Following Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Underwent allogeneic hematopoietic stem cell transplantation (HSCT).\n2. Documented EBV infection, defined as either:\n\n   EBV DNAemia (EBV-DNA ≥400 copies\u002FmL in plasma), or Pathologically confirmed EBV-associated lymphoproliferative disease with positive EBER by in situ hybridization.\n3. Age ≥18 years, regardless of gender.\n4. Negative for HIV, HBV, and HCV.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n6. Provision of signed informed consent prior to any study-related procedures. For patients aged 18 or above, consent must be provided by the patient themselves or an immediate family member. If obtaining consent directly from the patient is deemed medically detrimental to their condition, consent may be provided by a legal guardian or an immediate family member.\n\nExclusion Criteria:\n\n* 1\\. Presence of uncontrolled infection requiring mechanical ventilation or hemodynamic instability at the time of enrollment.\n\n  2\\. Diagnosis of clinically significant severe hepatic insufficiency (defined as Child-Pugh Class C) within 5 days prior to enrollment.\n\n  3\\. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding 5 times the upper limit of normal (ULN), or serum total bilirubin exceeding 2 times ULN, within 5 days prior to enrollment.\n\n  4\\. Diagnosis of end-stage renal dysfunction with a creatinine clearance rate of \\\u003C10 mL\u002Fmin within 5 days prior to enrollment.\n\n  5\\. Concurrent diagnosis of moderate hepatic insufficiency (defined as Child-Pugh Class B) and moderate renal dysfunction (defined as creatinine clearance rate \\\u003C50 mL\u002Fmin).\n\n  6\\. Cardiac function or disease meeting any of the following criteria:\n  1. Long QT syndrome or QTc interval \\>480 ms.\n  2. Complete left bundle branch block, second-degree or third-degree atrioventricular block.\n  3. Severe, uncontrolled arrhythmia requiring pharmacological intervention.\n  4. New York Heart Association (NYHA) functional classification ≥ Class II.\n  5. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n  6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other clinically significant arrhythmia requiring treatment within 6 months prior to enrollment; history of clinically significant pericardial disease; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n\n     7\\. Presence of uncontrolled severe acute graft-versus-host disease (aGVHD). 8. Evidence of active HIV replication prior to enrollment; detectable HCV antibody and HCV-RNA positivity within 90 days prior to enrollment; or HBsAg positivity. Known seropositivity for HIV or active hepatitis C virus.\n\n     9\\. Presence of psychiatric disorders or other conditions that would compromise the patient's ability to comply with study treatment and monitoring requirements.\n\n     10\\. Inability or unwillingness to provide written informed consent. 11. Patients deemed ineligible by the investigator due to other specific circumstances.","18 Years",{"count":126,"type":20},20,[24],"EBV DNAemia is defined as the presence of EBV-DNA load in peripheral blood exceeding the normal threshold, serving as a key diagnostic indicator for EBV-associated post-transplant lymphoproliferative disorder (EBV-PTLD). According to the European Conference on Infections in Leukemia (ECIL-6) guidelines, regular monitoring of peripheral blood EBV-DNA levels via quantitative real-time PCR (qPCR) is recommended starting from the first month after allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a weekly frequency sustained for at least 4 months post-transplant. For HSCT patients who develop EBV DNAemia, preemptive therapy should be initiated promptly. EBV-PTLD is a serious complication that may progress rapidly; if not diagnosed and treated in a timely manner, mortality rates can reach 60-80%. Current guidelines recommend CD20 monoclonal antibody (rituximab) as the first-line preemptive treatment. The response rate to rituximab is approximately 84%. The typical regimen consists of 375 mg\u002Fm² per dose, administered weekly, with 1-4 doses generally sufficient to achieve treatment goals. However, a subset of patients exhibits poor response to first-line therapy and requires second-line interventions, such as EBV-specific cytotoxic T lymphocytes (EBV-CTLs), donor lymphocyte infusion, or combination chemotherapy.\n\nZuberitamab is a novel anti-CD20 monoclonal antibody and the first Class 1 innovative biologics targeting CD20 developed in China. Preclinical studies have demonstrated that zuberitamab exhibits stronger antibody-dependent cellular cytotoxicity (ADCC) activity compared to rituximab. In a pivotal Phase III registrational clinical study, zuberitamab combined with CHOP (Hi-CHOP) was evaluated head-to-head against R-CHOP in patients with diffuse large B-cell lymphoma (DLBCL). The results showed an improvement in the complete response (CR) rate by more than 8% (85.7% vs. 77.3%, P = 0.038). These findings indicate that zuberitamab holds significant advantages over rituximab in terms of both biological activity and clinical efficacy. Based on this evidence, we have initiated a Phase II clinical trial to evaluate the efficacy and safety of zuberitamab as first-line preemptive therapy for EBV infection. This is a prospective Phase II clinical trial enrolling patients with EBV infection following transplantation. Zuberitamab will be administered as first-line preemptive therapy.",[130,28],"HSCT","NOT_YET_RECRUITING","2025-11-21",{"date":134,"type":48},"2025-12-03",{"date":136,"type":20},"2026-01-14",{"date":138,"type":20},"2026-10-31",{"name":140,"class":89},"Institute of Hematology & Blood Diseases Hospital, China",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":149,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100426407","phase-3-multivirus-specific-t-cell-transfer-post-sct-vs-adv-cmv-and-ebv-infections-100426407","NCT04832607","Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections","Treatment of Chemo-refractory Viral Infections After Allogeneic Stem Cell Transplantation With Multispecific T Cells Against CMV, EBV and AdV: A Phase III, Prospective, Multicentre Clinical Trial","TRACE","Inclusion Criteria:\n\n1. Adult or paediatric patients (\\> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection refractory to standard antiviral treatment for two weeks (defined as no decrease or insignificant decrease of less than 1log in viral load over two weeks) as confirmed by quantitative blood PCR analysis.\n2. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection.\n3. Written informed consent given (patient or legal representative) prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Patient with acute GvHD \\> grade II or extensive chronic GvHD at the time of IMP transfer\n2. Patient receiving steroids (\\>1 mg\u002Fkg BW Prednisone equivalent) at Screening.\n3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. Prescheduled prophylactic DLI ≤3x105 T cells\u002Fkg BW in case of T-cell depleted HSCT is not considered an exclusion criterion.\n4. Patient with organ dysfunction or failure as determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30%\n5. Concomitant enrolment in another clinical trial interfering with the endpoints of this study\n6. Any medical condition which could compromise participation in the study according to the investigator's assessment\n7. Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study\n8. Second line or experimental antiviral treatment other than Ganciclovir\u002FValganciclovir, Foscarnet, Cidofovir and Rituximab until 8 weeks after IMP Infusion or prophylactic Treatment other than Aciclovir or Letermovir throughout the study except approved by sponsor\n9. Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test.\n10. Female patient who is pregnant or breast-feeding. Female patient of child-bearing potential (i.e. post menarche and not surgically sterilized) or male patient of reproductive potential not willing to use an effective method of birth control from Screening until the last follow-up visit (FU6, Visit 8).\n\n    Note: Women of childbearing potential must have a negative serum pregnancy test at study entry ≤7 days before IMP administration on Day 0. Acceptable birth control methods are hormonal oral contraceptive ('pill'), contraceptive injection or patch, intrauterine pessar or the combination of two barrier methods. The combination of female and male condomes is NOT acceptable. If the male partner is sterilized, no further contraceptive is required. Women of post-menopausal status (no menses for 12 months without an alternative medical cause) are also not required to use contraceptives during the study.\n11. Known hypersensitivity to iron dextran\n12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.","2 Months",{"count":151,"type":20},149,[153],"PHASE3","Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.",[156,28,29,157],"AdV Infection","Stem Cell Transplant Complications","2025-07-15",{"date":160,"type":48},"2025-07-18",{"date":162,"type":48},"2019-08-27",{"date":164,"type":20},"2028-09",{"name":166,"class":89},"Tobias Feuchtinger",33,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100386173","phase-4-study-to-evaluate-the-efficacy-of-2lebv-and-2lxfs-on-asthenia-in-patients-with-an-epstein-barr-virus-infection-100386173","NCT04308278","Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection","Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection.","EBVAST","Pré-Inclusion Criteria:\n\n* Patients, male or female, aged 12 years and older,\n* Patient with fatigue for 1 month or more,\n* Patient with at least two other symptoms among the following: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsil, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders.\n* Patient (and\u002For parents if necessary) agrees to perform serology for the study,\n* Patient (and\u002For parents if necessary) agrees to perform lymphocyte typing for the study during the pre-inclusion visit,\n* Patients (and\u002For parents if necessary) having the faculties to understand and respect the constraints of the study,\n* Signature of the Informed Consent Form by the patient (and\u002For parents if necessary).\n\nInclusion Criteria:\n\n\\- Patient who have a positive serology for EBV (IgG and\u002For IgM positive).\n\nExclusion Criteria:\n\n* Patient who have received any treatment with the 2LEBV® or 2LXFS®,\n* Patients who have received any homeopathic treatment in the previous 2 months prior to the study,\n* Patients under immunosuppressive treatment,\n* Patient undergoing treatment for psychiatric disorders,\n* Patients having received immunotherapy or micro-immunotherapy during the last 3 months,\n* Patients with known lactose intolerance,\n* Pregnant or breastfeeding women,\n* Patients who participated in a clinical study in the previous 2-months period,\n* Patients (and\u002For parents of patients if necessary) who are not sufficiently motivated to engage on the total study follow-up period, or likely to travel or to move before the end of the study,\n* Patients with severe immunodeficiency disease requiring long term treatment (\\*) or patients under chemotherapy or radiotherapy,\n* Patients under homeopathic or phytotherapy treatment,\n* Patients addicted to or using recreational drugs,\n* Patient under guardianship and\u002For curatorship, (\\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV\u002FAIDS, terminal cancer.","12 Years",{"count":178,"type":20},88,[180],"PHASE4","Worldwide, 95% of adults are infected with Epstein-Barr Virus (EBV). These infections may cause different diseases. In most cases, EBV infection is asymptomatic because of a highly effective host immune response. Some individuals develop infectious mononucleosis (a self-limiting lymphoproliferative disorder in adolescents and young adults that is considered to be the primary infection), while others develop chronic fatigue syndrome, EBV-associated lymphoid, or epithelial malignancies.\n\nToday, there is no available treatment to treat and destroy EBV. The treatment is essentially symptomatic (treatment of the symptoms and not of the virus itself) with analgesics for pain for example.\n\nThe studied drugs are 2LEBV® and 2LXFS®, from Labo'Life company, and the treatment schema is the same for the two drugs: it consists in taking the content of one capsule per day, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment.\n\nThe duration of treatment will be of 6 months of continuous intake of the content of 1 capsule\u002Fday.\n\nThe aim of this study is to provide additional information on effectiveness on the 2LEBV® and 2LXFS®in the treatment of EBV chronic and acute infections, and in particular to demonstrate their effectiveness versus placebo in the reduction of asthenia and other symptoms in EBV infection.",[28],"2024-10-29",{"date":185,"type":48},"2024-10-30",{"date":187,"type":48},"2021-01-22",{"date":189,"type":20},"2026-08-30",{"name":191,"class":55},"Labo'Life",12,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":200,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":56},"100526529","phase-1-clinical-study-of-ebv-tcr-t-cells-for-ebv-associated-hemophagocytic-lymphohistiocytosis-or-ebv-infection-100526529","NCT06135922","Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection","Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection","Inclusion Criteria:\n\n* Age 1-60 years, gender unlimited.\n* Diagnosed with EBV associated-hemophagocytic lymphohistiocytosis (HLH) or EBV infection.\n* Fully understood and informed the study and signed the ICF.\n* Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age\\\u003C16y).\n* TCRT-T cell donor inclusion criteria: 1)Age \\>=8 years, gender unlimited; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3\u002F6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8\\~4) × 10\\^9\u002FL; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.\n\nExclusion Criteria:\n\n* Patients with uncontrolled active aGVHD one day before TCR-T cell infusion.\n* Patients with severe kidney disease (Cr \\> 3×normal value), liver damage (TBIL \\>2.5×upper limit of normal value, ALT and AST \\> 3×upper limit of normal value) or heart failure (NYHA heart function grade IV or left ventricular ejection fraction\\\u003C50%) one week before TCR-T cell infusion.\n* Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.\n* Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.\n* Have tumours, active and uncontrolled malignant diseases.\n* Serologically positive for HIV-Ab or TAP-ab.\n* Pregnant or lactating women.\n* Men and their partners or women of childbearing potential refused contraception during the study period.\n* Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.\n* Participated in any other clinical study of drugs and medical devices before 4 weeks of enrollment.\n* Allergy to albumin.\n* TCRT-T cell donor exclusion criteria: 1) pregnant woman; 2) Serologically positive for HBsAg, HCV-Ab, HIV-Ab or TAP-ab; 3) EBV-DNA or CMV-DNA positive; 4) other uncontrolled infection; 5) Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.","1 Year","60 Years",{"count":203,"type":20},9,[23],"This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) or EBV infection",[207,28],"EBV-associated Hemophagocytic Lymphohistiocytosis","2023-11-12",{"date":210,"type":48},"2023-11-18",{"date":212,"type":48},"2023-08-01",{"date":214,"type":20},"2026-12-31",{"name":216,"class":89},"Chinese PLA General Hospital",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":226,"phases":4,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":56},"100323488","surveillance-and-tracking-the-outcomes-of-chronic-latent-ebv-infection-100323488","NCT03491605","Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection","Study to Surveil and Track the Outcomes of Chronic Latent EBV Infection Based on Healthy Volunteers Undergoing Routine Inspection","Inclusion Criteria:\n\n1. immunocompetent subjects who was found to have high EBV-DNA load （\\>1×103 copies\u002Fml）in peripheral blood during the physical examination\n2. Willing to be followed up by telephone or face-to-face interview\n\nExclusion Criteria:\n\n1. Subjects with defined immunodeficiency\n2. Subjects who have taken or are going to take immunosuppressive drugs.\n3. Subjects Diagnosed a validated hematopathy\n4. Subjects diagnosis as precancerous lesion or malignant tumor and the life expectancy is less than 1 year.\n5. psychological illness which does not allow subjects to understand the study and participate following his own free will\n6. Pregnant woman\n7. no written informed consent",{"count":225,"type":20},10000,"OBSERVATIONAL","Immunocompetent subjects with high load of Epstein-Barr virus DNA (EBV-DNA) in peripheral blood will be enrolled and prospectively followed up to track the natural histories of the chronic high load of EBV virus. The primary goal of this study is to explore the association of peripheral high load of EBV with the hematological malignancies, and second goal is to investigate the genetic mechanisms of immune escape and tumorigenesis of chronic EBV infection.",[28],[230],"chronic EBV infection, hemophagocytic lymphohistiocytosis","2021-02-09",{"date":233,"type":48},"2021-02-10",{"date":235,"type":48},"2019-07-01",{"date":237,"type":20},"2029-12-31",{"name":239,"class":89},"Huazhong University of Science and Technology"]