[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04722029":3,"trial-entities:NCT04722029":98,"trial-summary:NCT04722029":101},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":45,"sex":46,"minimum_age":17,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":70,"locations":73,"central_contacts":88,"overall_officials":92,"references":96,"see_also_links":97},"NCT04722029","STUDY00001291","Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections","Open-Label Pilot Study of Haploidentical Donor Adenovirus Specific T Lymphocytes (ADV-VSTS) for the Treatment of Refractory Adenovirus Infection and\u002For Disease in Hospitalized Patients","RECRUITING","2027-10-01","2025-05","2025-05-13","2021-10-01","Nationwide Children's Hospital","OTHER",true,"This open-label, single-arm, phase I\u002FII clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.",null,[19],"Adenovirus Infection",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},12,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BIOLOGICAL","Adenovirus Specific T lymphocytes","ADV-VSTs is being proposed for the treatment of refractory ADV infection and\u002For disease in these populations using haploidentical donors for ease of donor selection, antiviral immunity, coupled with a high-throughput antigen stimulation\u002FIFN-γ capture system (Miltenyi Biotec, CliniMACS Prodigy® System) for rapid and less costly isolation of ADV-VSTs.",[35],"Recipient",[37,41],{"measure":38,"description":39,"timeFrame":40},"Safety by measuring unacceptable toxicities","Safety will be assess at 28 days post ADV-VSTS infusion. Safety is defined as presentation of unacceptable toxicities, measured by grade III-IV acute GVHD within 28 days, solid organ rejection\u002F graft failure within 28 days, grade \\>4 infusional toxicity within 7 days of infusion, and grade 4-5 adverse events within 28 days per CTCAE 5.0.","7-28 days",{"measure":42,"description":43,"timeFrame":44},"Efficacy by measuring viral load","Percentage of patients with ≥1 log decrease in ADV viral load. ADV viral load will be monitored by quantitative ADV PCR weekly until negative PCR. Response will be assess on day 28 post ADV-VSTS infusion defined as complete response, partial response, stable disease or progressive disease","28 days",[],"ALL","60 Years",false,{"inclusion":50,"exclusion":55,"raw_text":69},[51,52,53,54],"Age 0 days to 60 years with one of the following conditions:","And must meet at least 1 of the following criteria.","Negative pregnancy test in female patients if applicable (childbearing potential)","Written informed consent and\u002For signed assent line from patient, parent or legal guardian prior to any study-related procedures.",[56,57,58,59,60,61,62,63,64,65,66,67,68],"Receipt of anti-thymocyte globulin (ATG), alemtuzumab, cytoxan, or other T-cell depleting drugs or monoclonal antibodies within 28 days from enrollment","Receiving corticosteroid (prednisone equivalent) ≥ 0.5mg\u002Fkg\u002Fday or ≥ 20mg\u002Fday at the time of enrollment","Recipients of allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood or umbilical cord blood)","Evidence of uncontrolled infection (except ADV) as follows:","Patient with poor performance status determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30% (Table 5)","Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s)","During the study, treatment with other investigational anti-adenoviral agents is prohibited until Week 12.","If patient has been treated with CMX001 (brincidofovir, BCV) prior to ADV-VST enrollment, BCV must be discontinued for at least 72 hours prior to ADV-VSTs infusion for washout based on known geometric mean elimination half-life of BCV (8 to 12 hours). 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.","Known hypersensitivity to iron dextran","Patients unwilling or unable to comply with the protocol or unable to give informed consent.","Known human anti-mouse antibodies","Inclusion Criteria:\n\n* Age 0 days to 60 years with one of the following conditions:\n\n  1. Patients who are solid organ transplantation recipients (renal, heart, lung, liver, pancreas, small bowel, multi-visceral) and are \\> 28 days post-transplant at the time of screening.\n  2. Patients with underlying malignancy who are receiving or have received chemotherapy within 6 months of screening.\n  3. Patients with known autoimmune or autoinflammatory conditions, not associated with a known underlying primary immunodeficiency\n  4. Patients who are receiving or have received systemic immunosuppressive therapies in the 30 days prior to screening including: biologic agents, calcineurin inhibitors, mTOR inhibitors, or corticosteroid\n  5. Patients without known immunocompromised conditions\n* And must meet at least 1 of the following criteria.\n\n  1. Documented ADV refractory infection (i.e., DNAemia detected by qualitative or quantitative PCR in the peripheral blood \\> 14 days or rising viral load in blood despite antiviral therapy \\>14 days).\n  2. Evidence of refractory ADV end organ disease (proven or probable as previously defined46, including pneumonitis, colitis, hepatitis, hemorrhagic cystitis etc.) despite antiviral therapy \\>14 days.\n  3. Medical intolerance to anti-viral therapies including renal toxicity (Cr \\>2) and\u002For bone marrow suppression (ANC \\\u003C1500, Hb \\\u003C10 and\u002For Plt \\\u003C50) or gastrointestinal manifestation (grade ≥2 diarrhea), or other related organ injury.\n  4. At high risk for antiviral failure due to history of recurrent ADV reactivations, or recently started on increased immunosuppressants.\n* Negative pregnancy test in female patients if applicable (childbearing potential)\n* Written informed consent and\u002For signed assent line from patient, parent or legal guardian prior to any study-related procedures.\n\nExclusion Criteria:\n\n* Receipt of anti-thymocyte globulin (ATG), alemtuzumab, cytoxan, or other T-cell depleting drugs or monoclonal antibodies within 28 days from enrollment\n* Receiving corticosteroid (prednisone equivalent) ≥ 0.5mg\u002Fkg\u002Fday or ≥ 20mg\u002Fday at the time of enrollment\n* Recipients of allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood or umbilical cord blood)\n* Evidence of uncontrolled infection (except ADV) as follows:\n\n  1. Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment\n  2. Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and evidence of response\u002Fstabilization on therapy for 1 week prior to enrollment\n  3. Progressing infection is defined as hemodynamic instability attributable to sepsis, or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection\n* Patient with poor performance status determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30% (Table 5)\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s)\n* During the study, treatment with other investigational anti-adenoviral agents is prohibited until Week 12.\n* If patient has been treated with CMX001 (brincidofovir, BCV) prior to ADV-VST enrollment, BCV must be discontinued for at least 72 hours prior to ADV-VSTs infusion for washout based on known geometric mean elimination half-life of BCV (8 to 12 hours). Any medical condition which could compromise participation in the study according to the investigator's assessment\n* Known HIV infection\n* 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* Known hypersensitivity to iron dextran\n* Patients unwilling or unable to comply with the protocol or unable to give informed consent.\n* Known human anti-mouse antibodies",[71,72],"CHILD","ADULT",[74],{"facility":13,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"Columbus","Ohio","43205","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"Melinda Triplet, RN","CONTACT","614-722-6039","Melinda.Triplet@nationwidechildrens.org",{"lat":86,"lon":87},39.96118,-82.99879,[89],{"name":90,"role":82,"phone":91,"email":84},"Melinda Triplet","6147226039",[93],{"name":94,"affiliation":13,"role":95},"Eunkyung Song, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":99,"biomarkers":100},[19],[],{"nct_id":4,"found":15,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an open-label, single-arm study, meaning everyone receives the treatment and researchers know what treatment is given. It is a Phase I\u002FII trial, which typically looks at safety and early effectiveness.","completed","Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes for Adenovirus Infections","This study is testing a treatment called Adenovirus Specific T lymphocytes (ADV-VSTs) for serious adenovirus infections that haven't responded to other treatments. These special immune cells come from a related donor. The study aims to see how safe ADV-VSTs are and if they can reduce the amount of virus in your body. You might be able to join if you are 60 years old or younger and have had an organ transplant or cancer treatment. The study is currently unclear on its recruitment status and plans to enroll 12 participants.","Safety will be measured between 7 and 28 days after treatment, and viral load will be measured at 28 days.",90,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]