[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenovirus-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenovirus-infection":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,80,101,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100298003","phase-1-antigen-specific-cytotoxic-t-cells-in-the-treatment-of-opportunistic-infections-100298003",false,"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.","ALL","6 Months","80 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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.",[28,29,30,31,32,33,34],"Pathogen Infection","EBV Infection","CMV Infection","Adenovirus Infection","BKV Infection","Fungus Infection","Tuberculosis",[36,37,38,39],"CTL","Virus CTL","Fungus CTL","TB CTL","RECRUITING","2026-06-18",{"date":43,"type":44},"2026-06-22","ACTUAL",{"date":46,"type":44},"2026-06-01",{"date":48,"type":21},"2030-12-31",{"name":50,"class":51},"Shenzhen Geno-Immune Medical Institute","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":52},"100447036","phase-1-study-assessing-the-feasibility-safety-and-efficacy-of-genetically-engineered-glucocorticoid-receptor-knock-out-virus-specific-ctl-lines-for-viral-infections-in-immunosuppressed-cancer-patients-100447036","NCT05101213","Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients","Inclusion Criteria:\n\n* Patients \\> or = 18 years of age or older.\n* For BKV, ADV or CMV infections: Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood stem cells or single or double umbilical cord blood. For JC virus and COVID19 infection: no prior hematopoietic stem cell transplantation (HSCT) is required.\n* For BKV infection, patients need to have polymerase chain reaction (PCR) positive for BKV (in peripheral blood or urine) with consistent clinical symptoms.\n* For ADV infection, patients need to have PCR positive for ADV in peripheral blood AND\u002FOR patients need to fit criteria of probable or definitive adenovirus organ disease.\n* For CMV infection, patients need to have PCR positive for CMV in peripheral blood AND\u002FOR patients need to fit criteria of probable or definitive CMV disease.\n* For JCV, patients need to have documented JC viral encephalitis or JC end-organ disease.\n* For COVID-19 infection, patients need to have COVID-19 related pneumonia\u002Facute respiratory distress syndrome (ARDS) to be enrolled, defined as patients with a positive COVID-19 test (bronchoalveolar lavage \\[BAL\\], nasal or pharyngeal) and radiological and clinical signs of pneumonia or ARDS.\n* Written informed consent from patient or designated power of attorney.\n* Subjects are also are required to consent to PA17-0483 for long term follow up per the guidelines set forth by the Food and Drug Administrations' (FDA's) Biologic Response Modifiers Advisory Committee (BRMAC).\n* Negative pregnancy blood test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use at least two forms of birth control during the study and for at least 6 months after stopping treatment. Acceptable forms of birth control include intrauterine device (IUD), hormonal methods (birth control pills, injections, and implants), condoms, diaphragms, tubal ligation, or vasectomy.\n\nExclusion Criteria:\n\n* Patients who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or campath within 28 days of enrollment.\n* Patients with other uncontrolled infections (excluding human immunodeficiency virus \\[HIV\\]\u002Facquired immunodeficiency syndrome \\[AIDS\\]). For bacterial infections, patients must be receiving definitive therapy and have signs of improving infection prior to enrollment as determined by the principal investigator (PI). For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have signs of improving infection prior to enrollment as determined by the PI.\n* Patients with active steroid refractory graft versus host disease (GVHD).\n* Patients on immunosuppressive therapy other than tacrolimus, sirolimus or steroids\n* Active and uncontrolled relapse of malignancy. Patients with controlled malignancy on maintenance therapy would be eligible for the study.","18 Years",{"count":61,"type":21},30,[24],"This phase I trial tests the feasibility and safety of genetically modified cytotoxic T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with cancer. Viral infections are a leading cause of morbidity and mortality after hematopoietic stem cell transplantation, and therapeutic options for these infections are often complicated by associated toxicities. Genetically modified cytotoxic T-lymphocytes (CTLs) are designed to kill a specific virus that can cause infections. Depending on which virus a patient is infected with (ADV, BKV, CMV, JCV, or COVID-19), the CTLs will be designed to specifically attack that virus. Giving genetically modified CTLs may help to control the infection.",[31,65,66,67,68,69,70],"BK Virus Infection","Cytomegaloviral Infection","Hematopoietic and Lymphoid Cell Neoplasm","JC Virus Infection","Malignant Solid Neoplasm","Symptomatic COVID-19 Infection Laboratory-Confirmed","2026-04-13",{"date":73,"type":44},"2026-04-16",{"date":75,"type":44},"2023-01-06",{"date":77,"type":21},"2027-01-31",{"name":79,"class":51},"M.D. Anderson Cancer Center",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":87,"enrollmentInfo":4,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":99,"locationsCount":4},"100600984","tetravi-expanded-access-program-100600984","NCT07104591","TETRAVI Expanded Access Program","Expanded Access Use of Multivirus-Specific Cytotoxic T-Lymphocytes for Pediatric Patients With EBV, CMV, Adenovirus, or BK Virus Infections Post Allogeneic Stem Cell Transplant","Inclusion Criteria:\n\n* Patients \\\u003C18 years of age.\n* Patients who have undergone myeloablative or non-myeloablative allogeneic HSCT or CAR T therapy in the Sate of Texas (USA).\n* Have persistent, increasing, or recurrent infections with EBV, CMV, adenovirus, or BK virus despite standard treatment.\n* Treating physician must be based in Texas.\n* Must obtain IRB approval and submit a protocol to FDA with Letter of Authorization from Baylor.\n\nExclusion Criteria:\n\n* Patients with active uncontrolled infections unrelated to the viruses mentioned.\n* Use of certain immunosuppressive agents within 28 days.\n* Serious uncontrolled medical conditions or relapse of underlying disease.","17 Years","EXPANDED_ACCESS","This Expanded Access Program (EAP) allows qualified physicians within Texas to obtain access to multivirus-specific cytotoxic T lymphocytes (VSTs) developed under Baylor College of Medicine's TETRAVI program (NCT04013802) for the treatment of persistent or recurrent infections with EBV, CMV, adenovirus, or BK virus in pediatric patients being treated in Texas who have received allogeneic stem cell transplants and have no other suitable therapeutic options.",[91,92,31,65,68,93,94],"Epstein-Barr Virus Infection","Cytomegalovirus Infections","Viral Infections Post-Transplant","Post-Allogeneic Stem Cell Transplant Complications","AVAILABLE","2025-07-29",{"date":98,"type":44},"2025-08-05",{"name":100,"class":51},"Baylor College of Medicine",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":52},"100417924","phase-1-pilot-study-of-haploidentical-donor-adenovirus-specific-t-lymphocytes-to-treat-refractory-adenovirus-infections-100417924","NCT04722029","Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections","Open-Label Pilot Study of Haploidentical Donor Adenovirus Specific T Lymphocytes (ADV-VSTS) for the Treatment of Refractory Adenovirus Infection and\u002For Disease in Hospitalized Patients","ADV-VSTS","Inclusion Criteria:\n\n* Age 0 days to 60 years with one of the following conditions:\n\n  1. Patients who are solid organ transplantation recipients (renal, heart, lung, liver, pancreas, small bowel, multi-visceral) and are \\> 28 days post-transplant at the time of screening.\n  2. Patients with underlying malignancy who are receiving or have received chemotherapy within 6 months of screening.\n  3. Patients with known autoimmune or autoinflammatory conditions, not associated with a known underlying primary immunodeficiency\n  4. Patients who are receiving or have received systemic immunosuppressive therapies in the 30 days prior to screening including: biologic agents, calcineurin inhibitors, mTOR inhibitors, or corticosteroid\n  5. Patients without known immunocompromised conditions\n* And must meet at least 1 of the following criteria.\n\n  1. Documented ADV refractory infection (i.e., DNAemia detected by qualitative or quantitative PCR in the peripheral blood \\> 14 days or rising viral load in blood despite antiviral therapy \\>14 days).\n  2. Evidence of refractory ADV end organ disease (proven or probable as previously defined46, including pneumonitis, colitis, hepatitis, hemorrhagic cystitis etc.) despite antiviral therapy \\>14 days.\n  3. Medical intolerance to anti-viral therapies including renal toxicity (Cr \\>2) and\u002For bone marrow suppression (ANC \\\u003C1500, Hb \\\u003C10 and\u002For Plt \\\u003C50) or gastrointestinal manifestation (grade ≥2 diarrhea), or other related organ injury.\n  4. At high risk for antiviral failure due to history of recurrent ADV reactivations, or recently started on increased immunosuppressants.\n* Negative pregnancy test in female patients if applicable (childbearing potential)\n* Written informed consent and\u002For signed assent line from patient, parent or legal guardian prior to any study-related procedures.\n\nExclusion Criteria:\n\n* Receipt of anti-thymocyte globulin (ATG), alemtuzumab, cytoxan, or other T-cell depleting drugs or monoclonal antibodies within 28 days from enrollment\n* Receiving corticosteroid (prednisone equivalent) ≥ 0.5mg\u002Fkg\u002Fday or ≥ 20mg\u002Fday at the time of enrollment\n* Recipients of allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood or umbilical cord blood)\n* Evidence of uncontrolled infection (except ADV) as follows:\n\n  1. Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment\n  2. Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and evidence of response\u002Fstabilization on therapy for 1 week prior to enrollment\n  3. Progressing infection is defined as hemodynamic instability attributable to sepsis, or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection\n* Patient with poor performance status determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30% (Table 5)\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s)\n* During the study, treatment with other investigational anti-adenoviral agents is prohibited until Week 12.\n* If patient has been treated with CMX001 (brincidofovir, BCV) prior to ADV-VST enrollment, BCV must be discontinued for at least 72 hours prior to ADV-VSTs infusion for washout based on known geometric mean elimination half-life of BCV (8 to 12 hours). Any medical condition which could compromise participation in the study according to the investigator's assessment\n* Known HIV infection\n* Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.\n* Known hypersensitivity to iron dextran\n* Patients unwilling or unable to comply with the protocol or unable to give informed consent.\n* Known human anti-mouse antibodies","60 Years",{"count":111,"type":21},12,[24,25],"This open-label, single-arm, phase I\u002FII clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.",[31],"2025-05-08",{"date":117,"type":44},"2025-05-13",{"date":119,"type":44},"2021-10-01",{"date":121,"type":21},"2027-10-01",{"name":123,"class":51},"Nationwide Children's Hospital",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":52},"100209752","phase-2-a-study-to-assess-safety-and-feasibility-of-direct-infusions-of-donor-derived-virus-specific-t-cells-in-recipients-of-hematopoietic-stem-cell-transplantation-with-post-transplant-viral-infections-using-the-cytokine-capture-system-100209752","NCT02007356","A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®","A Phase I\u002FII Single-center Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®","CCS","Inclusion Criteria:\n\n* Adults \\> 18 years of age\n* Undergone allogeneic HSCT\n* Written informed consent\n* Patients with treatment refractory infections with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) will be included in case of fulfilling following criteria:\n\nPatient with Adenovirus Infection:\n\n1. Antiviral treatment with cidofovir for at least 7 days\n\n   * no virus load decrease ( ≤ 1 log) or virus load increase on treatment for at least 7 days or\n   * cluster of differentiation 3 (CD3) + cells \\\u003C 300\u002FµL on treatment for at least 7 days\n2. Or if antiviral treatment is contraindicated\n\nPatient with EBV:\n\n1\\. After receipt of at least one anti-cluster of differentiation 20 antigen (CD20)-antibody treat-ment (375 mg\u002Fm2)\n\n* No Virus load decrease (≤ 1 log) or virus load increase 7 days after receipt of treatment or\n* CD3+ cells \\\u003C 300\u002FµL 7 days after receipt of treatment or\n* Clinical progression\n\nPatient with CMV:\n\n1. Antiviral treatment with ganciclovir or foscavir for 14 days\n\n   \\- No Virus load decrease (≤ 1 log) or virus load increase on day 14\n2. Or if \\> 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells \\\u003C 300\u002FµL\n3. Or if antiviral treatment is contraindicated -\n\nPatient Exclusion Criteria:\n\n* graft-versus-host disease (GVHD) \\> grade 2 at the time point of planned infusion\n* Known allergy to iron-dextran or murine antibodies","65 Years",{"count":61,"type":21},[25],"To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment refractory post-transplant viral infections. The CCS has already been successfully used in clinical studies in Germany and United Kingdom (UK).",[31,137,92,138,139],"EBV","Cytokine Capture System","Allogenic Disease","2025-03-19",{"date":142,"type":44},"2025-03-20",{"date":144,"type":44},"2014-12",{"date":146,"type":21},"2026-12",{"name":148,"class":51},"University Hospital, Basel, Switzerland"]