[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cytomegaloviral-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cytomegaloviral-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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",false,"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.","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","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.",[25,26,27,28,29,30,31],"Adenovirus Infection","BK Virus Infection","Cytomegaloviral Infection","Hematopoietic and Lymphoid Cell Neoplasm","JC Virus Infection","Malignant Solid Neoplasm","Symptomatic COVID-19 Infection Laboratory-Confirmed","RECRUITING","2026-04-13",{"date":35,"type":36},"2026-04-16","ACTUAL",{"date":38,"type":36},"2023-01-06",{"date":40,"type":19},"2027-01-31",{"name":42,"class":43},"M.D. Anderson Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100312998","phase-1-multi-antigen-cmv-modified-vaccinia-ankara-vaccine-in-treating-pediatric-patients-with-positive-cytomegalovirus-undergoing-donor-stem-cell-transplant-100312998","NCT03354728","Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant","A Phase 1\u002F2 Clinical Study to Evaluate the Optimal Dose and the Protective Effect of CMV-MVA Triplex Vaccine in Pediatric Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* All subjects (or their guardians) must have the ability to understand and the willingness to sign a written informed consent; age appropriate assent will be obtained per institutional guidelines; to allow non-English patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible\n* Participant must be willing to comply with study and\u002For follow-up procedures, including willingness to be followed for one year post-HCT\n* Planned allogenic (allo)-HCT, with 9\u002F10 or 10\u002F10 (A, B, C, DRB1, DQB1) high\u002Fintermediate resolution HLA donor allele matching and with no T-cell depletion of graft\n* Planned related HCT with molecular 3\u002F6 HLA donor allele matching (haploidentical) (for phase I only)\n* CMV seropositive at the time of HCT\n* Conditioning and immunosuppressive regimens according to institutional guidelines are permitted\n* Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration\n* Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV); if hepatitis B virus (HBV) core seropositive, absence of HBV deoxyribonucleic acid (DNA) within 2 months of registration\n* Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for up to 90 days post-HCT; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately\n\nExclusion Criteria:\n\n* TRANSPLANT RELATED CRITERIA: Patients undergoing cord blood transplant (CB-HCT)\n* Any prior investigational CMV vaccine\n* Anti-CMV therapy in the last 6 months\n* Live attenuated vaccines\n* Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus \\[HPV\\]) or killed vaccine (e.g. influenza, pneumococcal)\n* Allergy treatment with antigens injections\n* Alemtuzumab, cyclophosphamide, ATG or any equivalent in vivo T-cell depleting agent; Note: Pre-transplant ATG is permitted\n* Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)\u002Fvaline (VAL), FOS, Cidofovir, CMX-001, maribavir; acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV)\n* Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment; intravenous immunoglobulin therapy (IVIG) is allowed\n* Other investigational product-concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited\n* Other medications that might interfere with the evaluation of the investigational product\n* Patients with congenital immune deficiency\n* Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible, the exception to this is patients with aplastic anemia, who are eligible\n* Pregnant women and women who are lactating; CMV-MVA Triplex risks to pregnant women are unknown; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the administered vaccine, also breastfeeding should be discontinued if the mother is enrolled on this study\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social\u002Fpsychological issues, etc\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issue related to feasibility\u002Flogistics)","1 Year","21 Years",{"count":55,"type":19},80,[22,57],"PHASE2","This phase I\u002FII trial studies the side effects and best dose of multi-antigen cytomegalovirus (CMV)-modified vaccinia ankara vaccine and to see how well it works in treating pediatric patients with positive cytomegalovirus who are undergoing donor stem cell transplant. Multi-antigen CMV-modified vaccinia ankara vaccine may help people resist CMV life-threatening complications.",[27,60],"Hematopoietic Cell Transplant Recipient","2025-10-02",{"date":63,"type":36},"2025-10-06",{"date":65,"type":36},"2018-05-11",{"date":67,"type":19},"2026-12-11",{"name":69,"class":43},"City of Hope Medical Center"]