[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660058":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":55,"studyPopulation":48,"armGroups":56,"interventions":63,"overallOfficials":76,"centralContacts":80,"locations":48,"responsibleParty":89,"collaborators":48,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":48,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":48,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":128,"overallStatus":140,"whyStopped":48,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":48},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":48},[9,13],{"measure":10,"description":11,"timeFrame":12},"Occurrence of Grade 3 or higher acute graft-versus-host disease (GVHD)","This outcome measures the number of participants who develop Grade 3 or higher acute graft-versus-host disease that is assessed as possibly, probably, or definitely related to vCTL infusion. Acute GVHD will be graded using the Center for International Blood and Marrow Transplant Research (CIBMTR) criteria.","From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion",{"measure":14,"description":15,"timeFrame":12},"Occurrence of Grade 3 or higher infusion-related reactions","This outcome measures the number of participants who experience a Grade 3 or higher infusion-related reaction that is assessed as possibly, probably, or definitely related to vCTL infusion. Infusion-related reactions will be graded using NCI CTCAE version 6.0.",[17,21,23,25,27,30,33,36,39,42,44,46],{"measure":18,"description":19,"timeFrame":20},"Cytomegalovirus (CMV) Overall Response Rate","This outcome measures the number of participants who achieve a virologic or clinical response following completion of vCTL therapy. Response categories include complete Response (undetectable viral load), partial Response (≥1-log reduction in viral load), mixed response (virologic or clinical improvement without both), stable disease (changes insufficient to qualify as a complete response, partial response or progression), and progressive disease (increase in viral load by quantitative polymerase chain reaction (qPCR) of at least 1-log from baseline). Viral load will be assessed by qPCR, and clinical symptoms will be evaluated by the study team.","Two weeks after the final vCTL infusion",{"measure":22,"description":19,"timeFrame":20},"Adenovirus (ADV) Overall Response Rate",{"measure":24,"description":19,"timeFrame":20},"Epstein Barr Virus (EBV) Overall Response Rate",{"measure":26,"description":19,"timeFrame":20},"BK polyomavirus (BKV) Overall Response Rate",{"measure":28,"description":29,"timeFrame":12},"Cytomegalovirus (CMV) Overall Survival","This outcome measures the length of time participants remain alive after receiving CMV vCTL therapy.",{"measure":31,"description":32,"timeFrame":12},"Adenovirus (ADV) Overall Survival","This outcome measures the length of time participants remain alive after receiving ADV vCTL therapy.",{"measure":34,"description":35,"timeFrame":12},"Epstein Barr Virus (EBV) Overall Survival","This outcome measures the length of time participants remain alive after receiving EBV vCTL therapy.",{"measure":37,"description":38,"timeFrame":12},"BK polyomavirus (BKV) Overall Survival","This outcome measures the length of time participants remain alive after receiving BK vCTL therapy. Overall survival will be evaluated separately for participants treated for CMV, adenovirus, EBV, and BK virus infections.",{"measure":40,"description":41,"timeFrame":12},"Cytomegalovirus (CMV) Virus Free Survival","This outcome measures the length of time participants remain alive and without detectable viral infection following vCTL therapy. Viral clearance will be assessed using quantitative PCR.",{"measure":43,"description":41,"timeFrame":12},"Adenovirus (ADV) Virus Free Survival",{"measure":45,"description":41,"timeFrame":12},"Epstein Barr Virus (EBV) Virus Free Survival",{"measure":47,"description":41,"timeFrame":12},"BK polyomavirus (BKV) Virus Free Survival",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"NA","SINGLE_GROUP","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":48},"NONE","Viral infection and reactivation are major causes of morbidity and mortality in individuals with inherited or acquired immunodeficiency, including recipients of allogeneic hematopoietic stem cell transplant and solid organ transplant. Cytomegalovirus, adenovirus, Epstein-Barr virus, and BK virus may cause severe, persistent, or progressive disease. Standard antiviral therapies may be ineffective, poorly tolerated, contraindicated, or limited by viral resistance.\n\nThis is a single-institution, open-label, prospective pilot basket study of donor-derived virus-specific cytotoxic T lymphocytes for treatment of refractory CMV, adenovirus, EBV, and\u002For BK virus infection. The vCTL product is manufactured from an adult related donor with at least a 3\u002F6 human leukocyte antigen (HLA) match to the recipient. Following leukapheresis, donor cells are stimulated with virus-specific peptide pools and enriched for interferon-gamma-secreting T cells using the CliniMACS Cytokine Capture System on the CliniMACS Prodigy platform.\n\nParticipants will receive vCTLs by slow intravenous push. Dose is based on donor-recipient HLA matching. Additional infusions of the same dose may be administered every 2 weeks for persistent detectable viral replication, up to a maximum of five infusions, provided safety and redosing criteria are met.\n\nSafety will be evaluated in aggregate across all viral cohorts, with particular focus on Grade 3 or higher acute graft-versus-host disease and Grade 3 or higher infusion-related reactions considered at least possibly related to vCTL infusion. Antiviral efficacy will be evaluated separately by virus type using quantitative polymerase chain reaction and clinical response assessments. Participants will be followed through 12 weeks after their final vCTL infusion.",[57],{"label":58,"type":59,"description":60,"interventionNames":61},"Virus-Specific Cytotoxic T Lymphocytes (vCTLs)","EXPERIMENTAL","Participants with refractory CMV, ADV, EBV, and\u002For BK virus will receive donor-derived virus-specific cytotoxic T lymphocytes. Participants may receive a multivirus-specific product when clinically indicated. The initial infusion is administered on Day 0. Repeat infusions may be administered every 2 weeks, up to five total infusions, for ongoing detectable viral replication if eligibility criteria are met.",[62],"Biological: Virus-Specific Cytotoxic T Lymphocytes (vCTLs)",[64],{"type":65,"name":58,"description":66,"armGroupLabels":67,"otherNames":68},"BIOLOGICAL","Donor-derived virus-specific cytotoxic T lymphocytes (vCTLs) targeting one or more of cytomegalovirus (CMV), adenovirus (ADV), Epstein-Barr virus (EBV), and BK virus. Cells are manufactured using the CliniMACS® Prodigy and CliniMACS Cytokine Capture System (IFN-γ) following stimulation with virus-specific PepTivator® peptide pools. vCTLs are administered by IV infusion at a dose of 2-3 × 10\\^4 CD3+ cells\u002Fkg recipient weight for HLA-matched related donors or 0.4-0.6 × 10\\^4 CD3+ cells\u002Fkg recipient weight for HLA-mismatched related donors. Additional infusions of the same dose may be administered every 2 weeks in subjects with ongoing clinically significant viral infection who continue to meet infusion eligibility criteria, for up to 5 total infusions. The intervention is intended for treatment of refractory viral infections in patients with inherited or acquired immunodeficiencies, including recipients of hematopoietic stem cell transplant.",[58],[69,70,71,72,73,74,75],"vCTLs","Virus-specific T cells","Cytotoxic T lymphocyte therapy","Gamma-Capture Virus-Specific Cytotoxic T Lymphocytes","CliniMACS-Manufactured Virus-Specific Cytotoxic T Lymphocytes","Virus-Specific T Cells (VSTs)","Donor-Derived Virus-Specific Cytotoxic T Lymphocytes",[77],{"name":78,"affiliation":5,"role":79},"Caitlin Elgarten, MD, MSCE","PRINCIPAL_INVESTIGATOR",[81,86],{"name":82,"role":83,"phone":84,"phoneExt":48,"email":85},"Megan Atkinson","CONTACT","215-590-2820","cttsbmtintake@chop.edu",{"name":87,"role":83,"phone":84,"phoneExt":48,"email":88},"Kellie Patterson, BSN, RN","pattersok3@chop.edu",{"type":90,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100660058","early-phase-1-25bt056-basket-study-of-viral-cytotoxic-t-lymphocytes-100660058",false,"NCT07873970","25BT056: Basket Study of Viral Cytotoxic T Lymphocytes","25BT056: Basket Study of Viral Cytotoxic T Lymphocytes in Children, Adolescents and Young Adults With Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplant, Solid Organ Transplant or in Primary Immunodeficiencies","Recipient Inclusion Criteria\n\n1. Subjects with inherited (e.g. SCID) or acquired immunodeficiency with evidence of refractory viral infection with one or more of CMV, adenovirus, EBV, or BK virus. Specifically:\n\n   1. Increasing viremia by quantitative PCR with increase from baseline over 7 days, or persistent detection after 14 days despite appropriate standard of care therapy (e.g. anti-viral therapy, withdrawal of immunosuppression), AND\u002FOR\n   2. Progressive symptomatic viral infection evidenced by persistent clinical symptoms or end-organ disease attributable to the viral infection that has not improved after at least 7 days of appropriate standard-of-care therapy, or develops new clinical manifestations despite standard-of-care therapy, AND\u002FOR\n   3. Antiviral resistance, or inability to receive appropriate antiviral therapy due to intolerance, toxicity, contraindication, or lack of a feasible antiviral treatment option.\n2. Age 0 - 29 years at time of consent\n3. Female subjects of reproductive potential, defined per Oncology clinical guidelines as all females ≥ 12 years old, or \\\u003C12 years old who have reached menarche, must have a negative urine or serum pregnancy test. Testing may be performed using serum human chorionic gonadotropin (HCG) or urine\n4. Subjects with reproductive potential must agree to use an effective method of birth control\n\nRecipient Exclusion Criteria\n\n1. Subjects with ≥ Grade 2 acute GVHD or moderate to severe chronic GVHD at the time of vCTL infusion\n2. Subjects receiving systemic steroids (\\> 0.5mg\u002Fkg\u002Fday prednisolone equivalent) at the time of vCTL infusion\n3. Receipt of donor lymphocyte infusion within the 4 weeks preceding vCTL infusion\n4. Receipt of thymoglobulin, alemtuzumab, or other T cell immunosuppressive monoclonal antibody within the 4 weeks preceding vCTL infusion\n5. End-organ involvement of virus in sites that may, in the opinion of the investigator, put the subject at risk of unacceptable toxicity e.g. retinitis, cerebritis, encephalitis\n6. Known HIV infection\n7. Any medical condition which could compromise participation in the study, in the opinion of the investigator\n8. Female subjects who are pregnant or breastfeeding\n\nDonor Inclusion Criteria\n\n1. Age ≥ 18 years old\n2. HLA match with the recipient of at least 3\u002F6. Donor may be the original transplant donor or a third party donor\n3. Consent to pre screening with PepTivator testing of T cell response to the relevant virus(es)\n4. Willing to undergo formal donor evaluation equivalent to that required for hematopoietic stem cell transplant (HSCT) donors\n5. Willing to consent to T cell processing under CHOP protocol CHP784 (IRB 04 004078) using the CliniMACS device\n\nDonor Exclusion Criteria\n\n1. Donors younger than 18 years old\n2. HLA match with the recipient less than 3\u002F6\n3. Refusal or inability to consent to PepTivator pre screening\n4. Unwillingness or inability to undergo formal donor evaluation (as required for HSCT donors)\n5. Refusal or inability to consent to T cell processing under The Children's Hospital of Philadelphia protocol (CHP784, IRB 04 004078) using the CliniMACS device\n6. Any medical, infectious, or other condition identified during evaluation that contraindicates donation per standard HSCT donor eligibility guidelines (e.g., active uncontrolled infection, significant cardiopulmonary disease, pregnancy) or that would preclude safe apheresis\u002FT cell collection as determined by the evaluating clinicians.","ALL","0 Years","29 Years",{"count":102,"type":103},35,"ESTIMATED","INTERVENTIONAL",[106],"EARLY_PHASE1","This study is evaluating the safety and effectiveness of virus-specific cytotoxic T lymphocytes (vCTLs) for treating difficult-to-control viral infections caused by cytomegalovirus (CMV), adenovirus (ADV), Epstein-Barr virus (EBV), or BK virus in children, adolescents, and young adults with weakened immune systems. Eligible participants include recipients of hematopoietic stem cell transplantation, solid organ transplantation, and patients with primary immunodeficiency disorders.\n\nvCTLs are immune cells collected from a related donor and selected to recognize and fight specific viruses. The cells are manufactured using the CliniMACS® Cytokine Capture System and administered by intravenous infusion. Additional infusions may be given if viral infection persists.\n\nThe study will assess the safety of vCTL therapy, including the risk of graft-versus-host disease (GVHD) and infusion-related reactions, as well as its ability to reduce viral infection, improve clinical outcomes, and support survival. Participants will be monitored for approximately 12 weeks after their final vCTL infusion. Participants will all receive vCTLs; there is no comparison group.\n\nParticipants will:\n\n1. Have donor-derived vCTLs manufactured for infusion using the CliniMACS Cytokine Capture System\n2. Receive the vCTLs through an intravenous infusion\n3. Be monitored for side effects and infusion reactions, viral levels through blood testing, clinical outcomes, including response to treatment, survival, and time without detectable virus",[109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"EBV Viremia","CMV Viremia","BK Viremia","Adenovirus","Post-transplant Lymphoproliferative Disorder","Viremia","Cytomegalovirus Enteritis","Adenovirus Infection","Epstein-Barr Virus Infection Reactivation","Epstein Barr Virus Infection","BK Virus Infection","Refractory Viral Infection","Opportunistic Viral Infection","Primary Immunodeficiency","Severe Combined Immunodeficiency (SCID)","Inherited Immunodeficiency Diseases","Acquired Immunodeficiency","Stem Cell Transplant Complications","Solid Organ Transplant Complications",[129,130,131,132,133,134,135,136,137,138,139],"Cytotoxic T Lymphocytes","vCTL","Virus-Specific T Cells","vCTL Therapy","Cellular Immunotherapy","Adoptive T-Cell Therapy","Antiviral Immunotherapy","Pediatric Transplant","Viral Reactivation","Resistant Viral Infection","CliniMACS Cytokine Capture System","NOT_YET_RECRUITING","2026-10-19",{"date":143,"type":144},"2026-10-22","ACTUAL",{"date":146,"type":103},"2026-11-01",{"date":148,"type":103},"2037-11",{"name":5,"class":6}]