[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03266653":3,"trial-entities:NCT03266653":177,"trial-summary:NCT03266653":182},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":55,"locations":59,"central_contacts":166,"overall_officials":173,"references":175,"see_also_links":176},"NCT03266653","NYMC 581","EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection","A Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection With Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients","RECRUITING","2027-12-31","2025-08","2025-08-08","2020-07-07","New York Medical College","OTHER",true,"Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.\n\nFunding Source: FDA OOPD",null,[19,20],"Epstein-Barr Virus Infections","Primary Immune Deficiency Disorder",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","cytotoxic t-lymphocytes","EBV specific CTLs will be generated from HLA related matched and mismatched donors in a GMP facility and administered to the patient with refractory CTLs.",[35],"Refractory EBV",[37],"CTLs",[39,43],{"measure":40,"description":41,"timeFrame":42},"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","Patients will be monitored for adverse events related to the infusion of EBV CTLs","Patients will be followed for 12 weeks after each infusion",{"measure":44,"description":45,"timeFrame":42},"Incidence of Response to Treatment [Efficacy]","Patients will be followed for improvement in viral infection by monitoring EBV PCR weekly for response to treatment with CTLs",[],"ALL","1 Month","79 Years",false,{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"1\\. Patients with Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with:\n\n* Increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and\u002For\n* progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly AND\u002FOR\n* Medical intolerance to anti-viral therapies including:\n* intolerance to rituximab Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.\n\nPerformance Status \\> 30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 yrs) Age: 0.1 to 79.99 years Females of childbearing potential with a negative urine pregnancy test\n\n2 Donor Eligibility 5.2.1 Related donor available with a T-cell response to the EBV MACS® GMP PepTivator antigen(s) causing the therapy-refractory EBV infection.\n\na. Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party related allogeneic donor (family donor \\> 1 HLA A, B, DR match to recipient) with IgG positive to EBV and\u002For a T-cell response at least to the viral MACS® GMP PepTivator EBV Select (containing among other antigens, NA-1, LMP2A and BZLF-1).\n\nAND Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).\n\nAND Obtained informed consents by donor or donor legally authorized representative prior to donor collection.\n\n3 Patient exclusion criteria:\n\nA patient meeting any of the following criteria is not eligible for the present study:\n\nPatient with acute GVHD \\> grade 2 or extensive chronic GVHD at the time of CTL infusion Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion Patient with poor performance status determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30% Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory EBV infection Any medical condition which could compromise participation in the study according to the investigator's assessment Known HIV infection 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\nKnown hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent.\n\nKnown human anti-mouse antibodies",[56,57,58],"CHILD","ADULT","OLDER_ADULT",[60,74,85,96,108,123,136,149],{"facility":61,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":71},"Children's Hosptial Los Angeles","Los Angeles","California","90027","United States",[67],{"name":68,"role":69,"email":70},"Neena Kapoor, MD","CONTACT","nkapoor@chla.usc.edu",{"lat":72,"lon":73},34.05223,-118.24368,{"facility":75,"status":8,"city":76,"state":63,"zip":77,"country":65,"contacts":78,"geoPoint":82},"University of California San Francisco","San Francisco","94158",[79],{"name":80,"role":69,"email":81},"Julia Chu, MD","Julia.Chu2@ucsf.edu",{"lat":83,"lon":84},37.77493,-122.41942,{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":65,"contacts":90,"geoPoint":93},"Johns Hopkins","Baltimore","Maryland","21287",[91],{"name":92,"role":69},"Kenneth Cooke, MD",{"lat":94,"lon":95},39.29038,-76.61219,{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":65,"contacts":101,"geoPoint":105},"Washington University","St Louis","Missouri","63130",[102],{"name":103,"role":69,"email":104},"Shalini Shenoy, MD","shalinishenoy@wustl.edu",{"lat":106,"lon":107},38.62727,-90.19789,{"facility":13,"status":8,"city":109,"state":110,"zip":111,"country":65,"contacts":112,"geoPoint":120},"Valhalla","New York","10595",[113,117],{"name":114,"role":69,"phone":115,"email":116},"Mitchell S Cairo, MD","914-594-2150","mitchell_cairo@nymc.edu",{"name":118,"role":119},"Mitchell S. Cairo, MD","PRINCIPAL_INVESTIGATOR",{"lat":121,"lon":122},41.07482,-73.77513,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":65,"contacts":128,"geoPoint":133},"Nationwide Children's Hosptial","Columbus","Ohio","43205",[129],{"name":130,"role":69,"phone":131,"email":132},"Dean Lee, MD, PhD","614-722-3550","Dean.Lee@nationwidechildrens.org",{"lat":134,"lon":135},39.96118,-82.99879,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":65,"contacts":141,"geoPoint":146},"Children's Hospital of Pennsylvania","Philadelphia","Pennsylvania","19104",[142],{"name":143,"role":69,"phone":144,"email":145},"Nancy Bunin, MD","215-590-2255","buninn@email.chop.edu",{"lat":147,"lon":148},39.95238,-75.16362,{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":65,"contacts":154,"geoPoint":163},"Medical College of Wisconsin\u002FChildren's Hospital of Wisconsin","Milwaukee","Wisconsin","53226",[155,159],{"name":156,"role":69,"phone":157,"email":158},"Julie A Talano, MD","414-955-4185","jtalano@mcw.edu",{"name":160,"role":69,"phone":161,"email":162},"Meredith Beversdorf, RN","(414) 266-5891","mbeversdorf@mcw.edu",{"lat":164,"lon":165},43.0389,-87.90647,[167,169],{"name":168,"role":69,"phone":115,"email":116},"Mitchell Cairo, MD",{"name":170,"role":69,"phone":171,"email":172},"Lauren Harrison","6172857844","lauren_harrison@nymc.edu",[174],{"name":168,"affiliation":13,"role":119},[],[],{"nct_id":4,"conditions":178,"biomarkers":181},[179,180],"EBV Infection","Inborn Error of Immunity",[],{"nct_id":4,"found":15,"summary":183,"prompt_version":193},{"design":184,"status":185,"heading":186,"summary":187,"follow_up":188,"word_count":189,"commitments":190,"compensation":191,"drugs_mentioned":192},"This is an interventional study with an unclear phase, planning to enroll 20 participants.","completed","EBV-specific Cytotoxic T-lymphocytes for Refractory EBV Infection","This study is testing a treatment called EBV-specific cytotoxic T-lymphocytes (CTLs) for people with Epstein-Barr Virus (EBV) infections that haven't responded to other treatments. These special immune cells are made from a related donor and are designed to fight the EBV infection. You might be able to join if you are between 1 month and 79 years old and have an EBV infection after a stem cell transplant, with a primary immune deficiency, or after an organ transplant. The study is looking at how safe the treatment is and if it helps reduce the infection. The current status of this study is unclear, and it plans to enroll 20 participants.","You will be followed for 12 weeks after each infusion.",110,"You will receive infusions of EBV specific CTLs and be followed for 12 weeks after each infusion to check for side effects and treatment response.","Not stated in the trial record.",[32],"v2"]