[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100209752":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":50,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":18,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"allogeneic HSCT","EXPERIMENTAL","The present study will evaluate and validate in a single-center, open-label, single arm fashion the safety and feasibility of direct infusions of donor-derived pathogen-specific IFN-γ positive T-cells in recipients of HSCT with post-transplant viral infection according to the previously clinically certified CCS® \\[3-6\\]. The Investigator will first generate and apply IFN-γ positive selected T-cells to recipients of HSCT with CMV, EBV or adenovirus as previously published. The Investigator aim is to include 6 patients from the University Hospital of Basel.\n\nWith confirmed safety the investigator will in the future perform an efficacy study and extend this treat-ment for other clinically relevant pathogens including human herpesvirus (HHV)-6, HHV-8, polyomaviruses JC and BK and fungi including Aspergillus fumigatus and Candida albicans, to other immunosuppressed patients such as solid organ transplant (SOT) recipients.",[13],"Biological: IFN-γ positive selected T-cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":18},"BIOLOGICAL","IFN-γ positive selected T-cells",null,[9],[21],{"name":22,"affiliation":23,"role":24},"Nina Khanna, Dr.","Universitätsspital Basel, Klinik für Infektiologie","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Nina Khanna, MD","CONTACT","+41-61-2652525 (Zentrale)","nina.khanna@usb.ch",[32],{"facility":33,"status":34,"city":35,"state":18,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Universitätsspital Basel","RECRUITING","Basel","4031","Switzerland","CH",{"type":40,"coordinates":41},"Point",[42,43],7.57327,47.55839,{"lat":43,"lon":42},[46,49],{"name":22,"role":28,"phone":47,"phoneExt":48,"email":30},"0041-61-","7325",{"name":22,"role":24,"phone":18,"phoneExt":18,"email":18},{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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",false,"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","ALL","18 Years","65 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","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).",[71,72,73,74,75],"Adenovirus Infection","EBV","Cytomegalovirus Infections","Cytokine Capture System","Allogenic Disease","2025-03-19",{"date":78,"type":79},"2025-03-20","ACTUAL",{"date":81,"type":79},"2014-12",{"date":83,"type":65},"2026-12",{"name":5,"class":6},1]