[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03266640":3,"trial-entities:NCT03266640":192,"trial-summary:NCT03266640":197},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":59,"locations":63,"central_contacts":182,"overall_officials":188,"references":190,"see_also_links":191},"NCT03266640","NYMC 580","Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)","A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections With Related Donor CMV Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients","RECRUITING","2027-12-31","2025-08","2025-08-08","2018-11-01","New York Medical College","OTHER",true,"CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) 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],"Cytomegalovirus Infections","Primary Immune Deficiency Disorder",[22,23,24],"Cytomegalovirus","CMV","cytotoxic t-lymphocytes","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},20,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","viral specific cytotoxic t-lymphocytes","CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.",[38],"Refractory CMV",[40],"CMV CTLs",[42,46],{"measure":43,"description":44,"timeFrame":45},"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","Patients will be monitored for adverse events following the administration of CMV CTLs","Patients will be followed for 12 weeks after each infusion",{"measure":47,"description":48,"timeFrame":49},"Incidence of Response to Treatment","Patients will be followed for improvement in viral infection by monitoring CMV PCR weekly for response to treatment with CTLs","Patients will be followed 12 weeks after each infusion",[],"ALL","1 Month","79 Years",false,{"inclusion":56,"exclusion":57,"raw_text":58},[],[],"1\\. Patients with refractory CMV infection post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with either\n\n* Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks of appropriate anti-viral therapy AND\u002FOR\n* Medical intolerance to anti-viral therapies including:\n* ANC \\\u003C 500\u002Fmm2 secondary to ganciclovir\n\n  * 2 renal toxicity with foscarnet And\u002For\n* known resistance to ganciclovir and\u002For foscarnet\n\nConsent: 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\nDonor Eligibility Related donor available with a T-cell response to the CMV MACS® GMP PepTivator antigen(s).\n\na. Third Party 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 CMV and\u002For a T-cell response to the CMV MACS® GMP PepTivator .\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 CMV CTL infusion Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of CMV CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CMV CTL infusion Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonal antibodies within 30 days Patient with poor performance status determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30% CMV retinitis Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory CMV infection.\n\nAny 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 CMV retinitis, meningitis, encephalitis, and\u002For cerebritis",[60,61,62],"CHILD","ADULT","OLDER_ADULT",[64,78,89,101,112,124,139,152,165],{"facility":65,"status":8,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":75},"Children's Hospital Los Angeles","Los Angeles","California","90027","United States",[71],{"name":72,"role":73,"email":74},"Neena Kapoor, MD","CONTACT","nkapoor@chla.usc.edu",{"lat":76,"lon":77},34.05223,-118.24368,{"facility":79,"status":8,"city":80,"state":67,"zip":81,"country":69,"contacts":82,"geoPoint":86},"University of California San Francisco","San Francisco","94158",[83],{"name":84,"role":73,"email":85},"Julia Chu, MD","Julia.Chu2@ucsf.edu",{"lat":87,"lon":88},37.77493,-122.41942,{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":69,"contacts":94,"geoPoint":98},"Indiana University","Indianapolis","Indiana","46202",[95],{"name":96,"role":73,"email":97},"Emily Hopewell, MD","emlhope@iu.edu",{"lat":99,"lon":100},39.76838,-86.15804,{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":69,"contacts":106,"geoPoint":109},"Johns Hopkins","Baltimore","Maryland","21287",[107],{"name":108,"role":73},"Kenneth Cooke, MD",{"lat":110,"lon":111},39.29038,-76.61219,{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":69,"contacts":117,"geoPoint":121},"Washington University","St Louis","Missouri","63130",[118],{"name":119,"role":73,"email":120},"Shalini Shenoy, MD","shalinishenoy@wustl.edu",{"lat":122,"lon":123},38.62727,-90.19789,{"facility":13,"status":8,"city":125,"state":126,"zip":127,"country":69,"contacts":128,"geoPoint":136},"Valhalla","New York","10595",[129,133],{"name":130,"role":73,"phone":131,"email":132},"Mitchell S Cairo, MD","914-594-2150","mitchell_cairo@nymc.edu",{"name":134,"role":135},"Mitchell S. Cairo, MD","PRINCIPAL_INVESTIGATOR",{"lat":137,"lon":138},41.07482,-73.77513,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":69,"contacts":144,"geoPoint":149},"Nationwide Children's Hosptial","Columbus","Ohio","43205",[145],{"name":146,"role":73,"phone":147,"email":148},"Dean Lee, MD, PhD","614-722-3550","Dean.Lee@nationwidechildrens.org",{"lat":150,"lon":151},39.96118,-82.99879,{"facility":153,"status":8,"city":154,"state":155,"zip":156,"country":69,"contacts":157,"geoPoint":162},"Children's Hospital of Pennsylvania","Philadelphia","Pennsylvania","19104",[158],{"name":159,"role":73,"phone":160,"email":161},"Nancy Bunin, MD","215-590-2255","buninn@email.chop.edu",{"lat":163,"lon":164},39.95238,-75.16362,{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":69,"contacts":170,"geoPoint":179},"Medical College of Wisconsin\u002FChildren's Hospital of Wisconsin","Milwaukee","Wisconsin","53226",[171,175],{"name":172,"role":73,"phone":173,"email":174},"Julie A Talano, MD","414-955-4185","jtalano@mcw.edu",{"name":176,"role":73,"phone":177,"email":178},"Meredith Beversdorf, RN","(414) 266-5891","mbeversdorf@mcw.edu",{"lat":180,"lon":181},43.0389,-87.90647,[183,184],{"name":130,"role":73,"phone":131,"email":132},{"name":185,"role":73,"phone":186,"email":187},"Lauren Harrison, RN","6172857844","lauren_harrison@nymc.edu",[189],{"name":130,"affiliation":13,"role":135},[],[],{"nct_id":4,"conditions":193,"biomarkers":196},[194,195],"Cytomegaloviral Infection","Inborn Error of Immunity",[],{"nct_id":4,"found":15,"summary":198,"prompt_version":207},{"design":199,"status":200,"heading":6,"summary":201,"follow_up":202,"word_count":203,"commitments":204,"compensation":205,"drugs_mentioned":206},"This is an interventional study planning to enroll 20 participants. The phase of the study is not specified.","completed","This study is testing a treatment called viral specific cytotoxic t-lymphocytes (CMV specific CTLs) for people with cytomegalovirus (CMV) infections that haven't responded to other treatments. These special immune cells are collected from a donor and then given to patients. The study aims to see how safe this treatment is and if it helps reduce the CMV infection. It includes children, adolescents, and young adults (ages 1 month to 79 years) who have CMV after a stem cell transplant, with certain immune problems, or after an organ transplant. The study is currently recruiting up to 20 participants.","Participants will be followed for 12 weeks after each infusion to check for side effects and treatment response.",97,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]