[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100284461":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":30,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":30,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":30,"enrollmentInfo":62,"targetDuration":30,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Case Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CMV specific adoptive t-cells","EXPERIMENTAL","This study involves a one-time infusion of the experimental CMV specific adoptive t-cells. After this infusion, patients will be followed for 4 weeks.",[13],"Biological: CMV specific adoptive t-cells",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","It is expected that the cell dose will be in the range of 10\\^3 - 10\\^5 virus - specific, antigen selected T cells per kg of recipient weight.",[9],[20],"immunotherapy",[22],{"name":23,"affiliation":24,"role":25},"Mari H Dallas, MD","University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","1-800-641-2422",null,"CTUReferral@UHhospitals.org",[33],{"facility":24,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Cleveland","Ohio","44106-5065","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-81.69541,41.4995,{"lat":44,"lon":43},[47,48],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":23,"role":25,"phone":30,"phoneExt":30,"email":30},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Mari Dallas","Principal Investigator","100284461","early-phase-1-t-cell-therapy-of-opportunistic-cytomegalovirus-infection-100284461",false,"NCT02982902","T Cell Therapy of Opportunistic Cytomegalovirus Infection","Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant","Inclusion Criteria:\n\n* Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration\n* Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)\n\n  * Patients may have asymptomatic viremia (\\>1000 copies\u002Fml) OR presence of symptoms secondary to CMV infection, AND\n  * Patients must have ONE OF THE NEXT FOUR CRITERIA:\n\n    * Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or\n    * New, persistent and\u002For worsening CMV-related symptoms, signs and\u002For markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or\n    * Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.\n    * Second recurrence of CMV viremia, CMV-related symptoms, signs and\u002For markers of end organ compromise.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women are excluded from this study.\n* Patients with opportunistic viral infections other than CMV.\n* Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (\\>0.5 mg\u002Fkg\u002Fday prednisone or its equivalent) as treatment\n* Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.\n* Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.\n\nDonor eligibility\n\n* Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3\u002F6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this).\n* Must have evidence of a serologic response (i.e. be seropositive) against CMV.\n* Age ≥ 18 years\n* Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program\n* Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood","ALL","3 Months",{"count":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"EARLY_PHASE1","The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.\n\nAdoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).",[70,71,72],"Cytomegalovirus Infections","Hematopoietic Stem Cell Transplant","Opportunistic Infections",[74,75,76],"Immunotherapy","T-Cell Therapy","Lymphoproliferative Disorder","2025-10-20",{"date":79,"type":80},"2025-10-22","ACTUAL",{"date":82,"type":80},"2020-05-27",{"date":84,"type":64},"2028-08",{"name":51,"class":6},1]