[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02532452":3,"trial-entities:NCT02532452":160,"trial-summary:NCT02532452":167},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":42,"secondary_outcomes":55,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":82,"locations":86,"central_contacts":137,"overall_officials":142,"references":145,"see_also_links":159},"NCT02532452","2015-4184","Third Party Viral Specific T-cells (VSTs)","Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients","RECRUITING","2027-12","2025-12","2025-12-16","2015-09-02","Children's Hospital Medical Center, Cincinnati","OTHER",true,"The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.","Viral reactivation and infection is a major cause of morbidity in immunocompromised patients (including HSCT recipients). In this study we will draw blood from unrelated (third party) donors and use the blood to generate viral specific T-cells (VSTs) with specificity for Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), and JC Virus. The VSTs will be infused into immunocompromised children with specific viral infections (EBV, CMV, ADV, BKV , or JC virus). Cells will be selected for infusion based on the recipient's HLA type and the viral specificity of the cells.",[19,20,21],"Viral Infection","Viral Reactivation","Infection in an Immunocompromised Host",[23,24,25,26,27,28],"Epstein-Barr Virus (EBV)","Adenovirus (ADV)","Cytomegalovirus (CMV)","T-Cells","Donor","BK virus (BKV)","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},750,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BIOLOGICAL","Viral Specific VST Infusion","VSTs will be infused into immunocompromised patients with evidence of viral infection or reactivation defined as any of the following:\n\n* Blood adenovirus PCR ≥ 1,000\n* Blood CMV PCR ≥ 500\n* Blood EBV PCR ≥ 9,000\n* Plasma BKV PCR \\>1,000\n* Plasma JC Virus PCR \\> 1,000\n* Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity by PCR or culture in one or more sites\n* Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis\n* Evidence of invasive EBV disease\u002Finfection, EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation, or EBV-associated malignancies\n* Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy\n* Evidence of PML or other CNS infection due to JC virus",[39],[43,47,51],{"measure":44,"description":45,"timeFrame":46},"Successful production of viral specific T-cells","Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.","Within 30 days post culture initiation",{"measure":48,"description":49,"timeFrame":50},"Percentage of patients who do not have infusional toxicity","Patients will be monitored for infusional toxicity","Through 30 minutes post infusion",{"measure":52,"description":53,"timeFrame":54},"Incidence of GVHD associated with VST infusion","Patients will be monitored for the development of VST associated GVHD","Through 30 days after infusion",[56,60],{"measure":57,"description":58,"timeFrame":59},"Presence of viral-specific T-cells","Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay","At 30 days after infusion",{"measure":61,"description":62,"timeFrame":59},"Viral burden","The viral burden will be assessed using the protocol-defined efficacy assessment.","ALL","2 Days",null,false,{"inclusion":68,"exclusion":75,"raw_text":81},[69,70,71,72,73,74],"Immunocompromised patient with evidence of viral infection or reactivation","Age \\>1 day","Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion","Clinical status must allow tapering of steroids to \\\u003C 0.5mg\u002Fkg prednisone or other steroid equivalent","Must be able to receive CTL infusion in Cincinnati","Informed consent obtained by PI or sub-investigator either in person or by phone",[76,77,78,79,80],"Active acute GVHD grades II-IV","Uncontrolled bacterial or fungal infection","Uncontrolled relapse of malignancy requiring treatment with chemotherapy","Infusion of ATG or alemtuzumab within 2 weeks of VST infusion","Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days","Inclusion Criteria:\n\n* Immunocompromised patient with evidence of viral infection or reactivation\n* Age \\>1 day\n* Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion\n* Clinical status must allow tapering of steroids to \\\u003C 0.5mg\u002Fkg prednisone or other steroid equivalent\n* Must be able to receive CTL infusion in Cincinnati\n* Informed consent obtained by PI or sub-investigator either in person or by phone\n\nExclusion Criteria:\n\n* Active acute GVHD grades II-IV\n* Uncontrolled bacterial or fungal infection\n* Uncontrolled relapse of malignancy requiring treatment with chemotherapy\n* Infusion of ATG or alemtuzumab within 2 weeks of VST infusion\n* Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days",[83,84,85],"CHILD","ADULT","OLDER_ADULT",[87,105,113,124],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":102},"Akron Children's Hospital","Akron","Ohio","44308","United States",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Courtney Culbertson, CNP","CONTACT","330-543-3338","cculbertson@akronchildrens.org",{"name":100,"role":101},"Megan Sampson, MD","PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},41.08144,-81.51901,{"facility":106,"status":107,"city":108,"state":90,"zip":109,"country":92,"geoPoint":110},"University of Cincinnati Medical Center","COMPLETED","Cincinnati","45219",{"lat":111,"lon":112},39.12711,-84.51439,{"facility":114,"status":8,"city":108,"state":90,"zip":115,"country":92,"contacts":116,"geoPoint":123},"Cincinnati Children's Hospital Medical Center","45229",[117,121],{"name":118,"role":96,"phone":119,"email":120},"Jamie Wilhelm","513-803-1102","Jamie.Wilhelm@cchmc.org",{"name":122,"role":101},"Michael Grimley, MD",{"lat":111,"lon":112},{"facility":125,"status":8,"city":126,"state":90,"zip":127,"country":92,"contacts":128,"geoPoint":134},"The Ohio State University Wexner Medical Center - James Cancer Hospital","Columbus","43210",[129,132],{"name":130,"role":96,"email":131},"Nicole Szuminski, MS, RN, CCRC","nicole.szuminski@osumc.edu",{"name":133,"role":101},"Polina Shindiapina, MD, PhD",{"lat":135,"lon":136},39.96118,-82.99879,[138,140],{"name":118,"role":96,"phone":139,"email":120},"(513) 803-1102",{"name":122,"role":96,"email":141},"Michael.Grimley@cchmc.org",[143],{"name":144,"affiliation":13,"role":101},"Michael Grimley, MD, MD",[146,150,153,156],{"pmid":147,"type":148,"citation":149},"40991376","DERIVED","Rubinstein JD, Pham G, Sridharan A, Khoury R, Wang YM, Hudda Z, Wilhelm J, Lichtenstein DA, Heyenbruch D, Cancelas JA, Davies SM, Lutzko C, Grimley MS. Outcomes with third-party virus-specific T cells after the use of single-antigen cell lines to predict HLA restriction. Blood Adv. 2025 Dec 23;9(24):6305-6313. doi: 10.1182\u002Fbloodadvances.2025017097.",{"pmid":151,"type":148,"citation":152},"36736781","Galletta TJ, Lane A, Lutzko C, Leemhuis T, Cancelas JA, Khoury R, Wang YM, Hanley PJ, Keller MD, Bollard CM, Davies SM, Grimley MS, Rubinstein JD. Third-Party and Patient-Specific Donor-Derived Virus-Specific T Cells Demonstrate Similar Efficacy and Safety for Management of Viral Infections after Hematopoietic Stem Cell Transplantation in Children and Young Adults. Transplant Cell Ther. 2023 May;29(5):305-310. doi: 10.1016\u002Fj.jtct.2023.01.027. Epub 2023 Feb 3.",{"pmid":154,"type":148,"citation":155},"34473237","Rubinstein JD, Zhu X, Leemhuis T, Pham G, Ray L, Emberesh S, Jodele S, Thomas S, Cancelas JA, Bollard CM, Hanley PJ, Keller MD, Grimley O, Clark D, Clark T, Lindestam Arlehamn CS, Sette A, Davies SM, Nelson AS, Grimley MS, Lutzko C. Virus-specific T cells for adenovirus infection after stem cell transplantation are highly effective and class II HLA restricted. Blood Adv. 2021 Sep 14;5(17):3309-3321. doi: 10.1182\u002Fbloodadvances.2021004456.",{"pmid":157,"type":148,"citation":158},"33216887","Nelson AS, Heyenbruch D, Rubinstein JD, Sabulski A, Jodele S, Thomas S, Lutzko C, Zhu X, Leemhuis T, Cancelas JA, Keller M, Bollard CM, Hanley PJ, Davies SM, Grimley MS. Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients. Blood Adv. 2020 Nov 24;4(22):5745-5754. doi: 10.1182\u002Fbloodadvances.2020003073.",[],{"nct_id":4,"conditions":161,"biomarkers":166},[162,163,164,165,19],"Adenovirus Infection","BK Virus Infection","Cytomegaloviral Infection","EBV Infection",[],{"nct_id":4,"found":15,"summary":168,"prompt_version":178},{"design":169,"status":170,"heading":171,"summary":172,"follow_up":173,"word_count":174,"commitments":175,"compensation":176,"drugs_mentioned":177},"This is an interventional study, meaning participants will receive a treatment. It aims to enroll 750 participants.","completed","Third Party Viral Specific T-cells (VSTs) for Viral Infections","This study is looking at a treatment called Viral Specific VST Infusion (a type of white blood cell therapy) for immunocompromised patients who have viral infections or reactivations. These infections can be caused by viruses like Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), or JC Virus. The VSTs are taken from healthy, unrelated donors and then given to patients. The goal is to see if these VSTs can be successfully made and given safely without causing serious side effects like graft-versus-host disease (GVHD). You could be eligible if you are immunocompromised, have one of these viral infections, and are at least 2 days old. The study is planning to enroll 750 participants, but its current status is unclear.","The study will track side effects for 30 minutes after infusion and for 30 days after infusion.",121,"Not specified in the trial record.","Not stated in the trial record.",[39],"v2"]