[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenovirus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenovirus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,76,97,194,222,251,276],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100453357","phase-1-r-mvst-cells-for-treatment-of-viral-infections-100453357",false,"NCT05183490","R-MVST Cells for Treatment of Viral Infections","Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells","Recipient Inclusion Criteria:\n\n* Men and women ages 18 years or older of all ethnic groups will be eligible for the treatment\n* Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and\u002For infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.\n* Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections\u002Freactivations will be eligible as long as at least one of those viral infections meet the criterium of \"refractory\".\n\nRecipient Exclusion Criteria:\n\n* Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. 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* Patients who receive corticosteroids at ≥ 0.5mg\u002Fkg prednisone or equivalent.\n* Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosupressive monoclonal antibodies in the last 28 days.\n* Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.\n* Patients who received extracorporeal photopheresis within the last 28 days.\n* Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.\n* Received donor lymphocyte infusion in last 28 days.\n* Evidence of GVHD ≥ grade 2\n* Evidence of biopsy-proven acute rejection in SOT recipients\n* Active and uncontrolled relapse of malignancy\n* Patients who are pregnant, or breastfeeding.\n* Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.\n* Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.\n\nDonor inclusion and exclusion criteria will be followed as per the most current BMT SOP (Donor selection, Donor evaluation and Donor Deferral).","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and\u002For symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion.\n\nSecondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.",[26,27,28,29],"Epstein-Barr Virus Infections","Cytomegalovirus Infections","Adenovirus","BK Virus Infection",[31,32],"Rapidly generated virus specific T cells (R-MVST)","Refractory viral reactivation","RECRUITING","2026-06-08",{"date":36,"type":37},"2026-06-10","ACTUAL",{"date":39,"type":37},"2022-05-03",{"date":41,"type":20},"2028-06",{"name":43,"class":44},"Columbia University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100336842","early-phase-1-donor-virus-specific-cmv-or-adv-ctl-to-treat-cmv-or-adv-reactivation-or-disease-after-solid-organ-or-hct-100336842","NCT03665675","Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT","Pilot Study of Haploidentical or Matched Donor Virus-Specific T-cells (Cytomegalovirus (CMV) or Adenovirus (AdV)) to Treat CMV or AdV Reactivation or Disease in Patients After Solid Organ or Hematopoietic Stem Cell Transplantation (HCT)","Inclusion Criteria:\n\n* Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant.\n* • Cohort A (CMV): Must have documented CMV disease or reactivation, as by:\n\n  * Viremia as detected by quantitative polymerase chain reaction (PCR) (\\> 500 IU\u002Fml) in the peripheral blood requiring treatment OR\n  * High risk for antiviral failure due to history of recurrent CMV reactivations or evidence of antiviral drug resistance, OR\n  * Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury\n\n    • Cohort B (AdV): Must have documented AdV infection or reactivation, as by:\n  * Symptomatic subject with any detectable viral load in blood, OR\n  * Symptomatic subject with qualitative AdV detection in compartment of current symptomatology, including stool, urine, and\u002For other specimens (bronchoalveolar lavage (BAL), nasal swab, CSF, etc.), irrespective of blood viral load, OR\n  * New, persistent, and\u002For worsening AdV-related symptoms, signs, and\u002For markers of end organ compromise while receiving antiviral therapy (ie cidofovir), OR\n  * Asymptomatic with a viral load \\> 1000 copies\u002Fml in peripheral blood, OR\n  * Unable to tolerate antiviral treatment due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury\n\n    * Karnofsky (age \\> 16 years) or Lansky performance score \\> 70 (age \\\u003C 16)\n    * Available seropositive haploidentical or matched donor who is without evidence of infection that would otherwise preclude donation\n    * Negative pregnancy test in female patients if applicable (childbearing potential, has not received a full-intensity conditioning regimen\n    * Written informed consent and\u002For signed assent line from patient, parent or guardian\n    * DONOR\n    * Human leukocyte antigen (HLA)-haploidentical or full-match to the patient as determined by institutional standards\n    * Cohort A: CMV seropositive, defined as detection of serum CMV immunoglobulin G (IgG)\n    * Cohort B: AdV seropositive, defined as detection of serum AdV IgG\n    * Age 18 or over\n    * Meet donor eligibility or suitability according to institutional standards. If the donor is deemed ineligible according to Foundation for the Accreditation of Cellular Therapy (FACT) standards, but is suitable for donation per institutional standards, the donor will be eligible for the protocol\n\nExclusion Criteria:\n\n* Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 21 days of screening for enrollment.\n* Receipt of \\> 0.5mg\u002Fkg\u002Fday of prednisone or steroid equivalent at the time of enrollment. Stable GVHD is permitted as long as patients are on stable dose steroids of less than or equal to 0.5 mg\u002Fkg\u002Fday of prednisone or steroid equivalent.\n* Evidence of uncontrolled infection as follows:\n\n  * Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.\n  * Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.\n  * Patients with hemodynamic instability attributable to bacterial sepsis or new symptoms, worsening physical signs or radiographic findings attributable to concomitant bacterial or fungal infection are excluded. Patients who require ventilator support for CMV pneumonitis are not excluded. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n* Receipt of donor lymphocyte infusion (DLI) within 28 days.\n* Patients with active acute graft versus host disease (GvHD) grades II-IV requiring \\> 0.5 mg\u002Fkg\u002Fday of prednisone or steroid equivalent or T-cell depleting immunosuppression.\n* Acute graft rejection in solid organ transplantation requiring augmented immunosuppression with T-cell depleting agents or steroids as mentioned above.\n* Active and uncontrolled relapse of malignancy.",true,"1 Year","85 Years",{"count":57,"type":20},20,[59],"EARLY_PHASE1","This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \\[CMV\\] specific cytotoxic T-lymphocytes \\[CTLs\\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \\[AdV\\] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.",[62,63,64,65,28],"Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Cytomegalovirus","Donor","Solid Organ Transplantation Recipient","2026-04-10",{"date":68,"type":37},"2026-04-15",{"date":70,"type":37},"2020-11-07",{"date":72,"type":20},"2026-12-20",{"name":74,"class":44},"Sumithira Vasu",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":45},"100490284","phase-2-haplo-identical-viral-specific-t-cells-for-treatment-of-cytomegalovirus-and-adenovirus-infections-after-hematopoietic-cell-transplantation-100490284","NCT05664126","Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation","Inclusion Criteria for Patients:\n\n* Patients who have undergone haploidentical HCT or a matched-sibling\u002Fmatched-unrelated donor HCT, and have CMV and\u002For ADV detected by PCR in the peripheral blood refractory to antiviral therapy per institutional BMTCT SOP 20.05.\n* Definition of \"refractory\" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy number (≥1 log) after 7 days of treatment.\n* Patients have no suspected or confirmed GVHD.\n* Availability of haploidentical donor for isolation of virus-specific T-cells.\n* Have not received a Donor Lymphocyte Infusion in the past 4 weeks.\n* Female patients of childbearing age must have a negative pregnancy test.\n* Subject, parent, or guardian are capable of giving signed informed consent.\n* Patients must have a shortening fraction \\>26% or left ventricular ejection fraction \\>40%.\n* Patients must have a bilirubin less than or equal to 2.5mg\u002FdL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.\n* Patients must have an estimated glomerular filtration rate (GFR) greater than 60mL\u002Fmin\u002F1.73m2 (may use estimated GFR that is auto calculated in the EHR).\n* Patients must be free of severe infection which upon determination of the principal investigator precludes therapy with VST.\n* Patients must have FVC \\>50% predicted or able to maintain pulse oximetry saturation \\> 92% on room air.\n* Gut diarrhea \\\u003C1 liter\u002Fday (adults) or \\\u003C20mL\u002Fkg\u002Fday (children) or if unable to quantify, then occurrence of 4 stools per day above baseline.\n* Patients must have engrafted with an ANC \\>500 cells\u002Fmm3 for 3 consecutive days.\n\nInclusion criteria for donors\n\n* Age ≥18 years.\n* At least single haplotype matched (≥3\u002F6) family member.\n* Donor will be identical to the stem cell donor (Cohort A) or different from the stem cell donor (Cohort B).\n* HIV negative.\n* For females of childbearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND not lactating with intent to breastfeed.\n* Regarding donation eligibility, is identified as either having completed the process of donor eligibility determination as outlined in 21CFR 1271 and agency guidance or does not meet 21CFR 1271 eligibility requirements but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21CFR.\n* Identified recipient with CMV and\u002For ADV reactivation post-HCT.\n\nExclusion Criteria for Patients:\n\n* Active GVHD.\n* Pregnancy.\n* Inability to provide consent.\n* Need for vasopressor or ventilatory support Patients receiving steroids \\>0.5 mg\u002Fkg prednisone equivalent at the time of VST infusion\n* Donor Lymphocyte Infusion within 4 weeks prior to VST infusion.\n* Receipt of Thymoglobulin or Alemtuzumab within 30 days of VST infusion.\n* Other severe uncontrolled concurrent infections (i.e. bacterial or fungal) that are not yet controlled on antimicrobial therapies.",{"count":83,"type":20},42,[85],"PHASE2","The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at St. Jude in treating the participant's infection.\n\nPrimary objective\n\nTo determine the efficacy of VSTs to achieve a ≥1 log10 reduction in CMV and\u002For ADV viral load in the peripheral blood 4 weeks after VST infusion.\n\nWhen the initial viral load is \\\u003C1 log10 above the threshold of detection, the objective is to achieve a reduction to below the threshold of detection.\n\nSecondary objectives\n\n* Determine the safety of VSTs when used to treat CMV and\u002For ADV viremia post-HCT.\n* Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion.\n* Assess the persistence of response for 6 months post-infusion.",[63,28],"2026-02-19",{"date":90,"type":37},"2026-02-23",{"date":92,"type":37},"2023-08-01",{"date":94,"type":20},"2029-12-31",{"name":96,"class":44},"St. Jude Children's Research Hospital",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":53,"sex":16,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":167,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":45},"100620537","risk-assessment-of-community-spread-of-multiple-endemic-infectious-diseases-in-a-one-health-perspective-100620537","NCT07358910","Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective","RACSMEI","Inclusion Criteria:\n\n* Residency in the village for more than 6 months;\n* Age between 2 and 75 years old at the time of inclusion;\n* For adults: provision of written consent;\n* For children aged 2-17 years: written parental consent form, verbal assent from children aged 13-17 years;\n\nExclusion Criteria:\n\n* Unable to understand or consent;\n* Under guardianship or deprived of liberty;\n* Medical conditions that impede survey participation;\n* Refusal to participate in the study.","2 Years","75 Years",{"count":107,"type":20},10000,"OBSERVATIONAL","RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.\n\nRACSMEI will improve understanding across multiple pathogens using a multidisciplinary One Health approach. We will answer key questions on burden, ecology, transmission and population immune status to inform targeted and culturally appropriate interventions. The project combines a nationally representative One Health survey, social-science methods, and multiplex, diverse diagnostics to efficiently test for 57 priority pathogens, including zoonotic and vector-borne agents, vaccine-preventable and elimination-targeted diseases, enteric, respiratory, and environmentally transmitted pathogens and selected neglected tropical diseases and parasites relevant to Cambodia.\n\nMathematical modelling will reconstruct and forecast transmission dynamics and assess the potential impact of future public-health strategies. By integrating intersectoral data and innovative methods, RACSMEI will generate actionable evidence for public-health authorities, support precision One Health interventions, and help reduce disease burden in affected communities. The project also aims to ensure the transferability of methods and insights to other countries facing similar challenges.",[111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,28,145,146,147,63,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166],"Dengue","Chikungunya","Zika Virus Infection","Japanese Encephalitis","West Nile Virus","Tick-borne Encephalitis (TBE)","Severe Fever With Thrombocytopenia Syndrome","Nipah Virus Infection","Hantavirus Infections","Hepatitis E","Brucellosis","Q Fever","Leptospirosis","Melioidosis","Influenza A and B","Malaria","Yellow Fever","Mayaro Fever","Usutu Virus Infection","Oropouche Fever","Rift Valley Fever","Arenavirus Infections","Measles","Mumps","Rubella","Human Papilloma Virus (HPV)","Rotavirus Disease","Pertussis","Diphteria","Tetanus","Varicella","Hepatitis A","Norovirus Infections","Enterovirus","Rhinovirus","Parvovirus","Respiratory Syncytial Virus (RSV)","Epstein Barr Virus","Salmonella Typhi","Vibrio Cholerae","Legionella Pneumophila Pneumonia","Mycoplasma","Chlamydia","Lymphatic Filariasis","Toxoplasma Gondii","Giardiasis","Entamoeba Histolytica","Leishmaniasis","Strongyloides Stercoralis Infection","Ascaris Lumbricoides","Trichuris Trichiura","Clonorchis Sinensis","Opisthorchis Viverrini","Schistosomiasis","Streptococcus Pneumoniae","Meningitis",[168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184],"Infectious disease","One Health","Population-based survey","Nationally representative survey","Seroepidemiology","Multiplex serology","Seroprevalence","Vector-borne diseases","Zoonoses","Vaccine-preventable diseases","Neglected tropical diseases","Transmission dynamics","Force of infection","Mathematical modelling","Spatial epidemiology","Precision public health","Cambodia","2026-01-14",{"date":187,"type":37},"2026-01-22",{"date":189,"type":37},"2025-12-18",{"date":191,"type":20},"2027-09-30",{"name":193,"class":44},"Institut Pasteur du Cambodge",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":4},"100610314","phase-3-phase-3-randomized-trial-for-refractory-adv-or-cmv-infection-with-family-matched-ctls-and-standard-of-care-soc-vs-soc-alone-100610314","NCT07225972","Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone","An Open-Label Prospective Randomized Trial of Family Donor-Derived ADV or CMV CTLs Plus Standard of Care (SOC) vs SOC Alone in Children, Adolescents and Young Adults Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Refractory ADV or CMV Infection\u002FViremia","Patient Eligibility Cohort 1 (ADV) -Patients with ADV infections (Cohort 1) (pneumonitis, hepatitis, cystitis, and\u002For colitis) post AlloHSCT with one or more of the following: Increasing or persistent ADV RT-PCR DNA (\\> 1000 ADV PCR copies) after 7 days of appropriate anti-viral therapy AND\u002FOR Medical intolerance to anti-viral therapies including one or more of the following: \\> grade 2 renal insufficiency secondary to cidofovir and\u002For other \\> grade 2 toxicities secondary to cidofovir AND\u002FOR Known resistance to cidofovir\n\nPatient Eligibility (Cohort 2) (CMV)\n\n-Patients with CMV infections (pneumonitis, hepatitis, colitis) with one or more of the following: Increasing or persistent CMV RT-PCR DNA (\\>1000 copies) after 7 days of appropriate anti-viral therapy AND\u002FOR Medical intolerance to anti-CMV antibiotic therapies: ANC \\> 500\u002Fmm3 secondary to ganciclovir AND\u002FOR \\> grade 2 renal toxicity secondary to either foscarnet or cidofovir AND\u002FOR Known resistance to ganciclovir and\u002For foscarnet\n\n* Consent: written informed consent given (by patient or legal representative) prior to any study related procedures\n* Performance Status \\>30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 years (BOTH COHORTS)\n* Age: 0.01 to 30.00 years (BOTH COHORTS)\n* Females of childbearing potential with a negative urine pregnancy test at study entry only (BOTH COHORTS)\n\nDonor Eligibility\n\n* Related donor available with a T-cell response to the ADV MACS PepTivators (Cohort 1) or CMV MACS PepTivator (Cohort 2). As defined in Appendix II, B, 8.2, the donor is considered suitable if the percentage of IFN+ T-cells is \\>0.01% after stimulation with ADV PepTivators (Cohort 1) or CMV PepTivators (Cohort 2).\n* Third-party related allogeneic donor: If original donor is not available or does not have a T-cell response to ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2), third party allogeneic donor (family donor \\> 3 HLA A, B, DR match to recipient) with a T-cell response at least to the ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2) AND\n* Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1) AND\n* Obtained informed consents by donor or donor legally authorized representative prior to donor collection\n\nPatient Exclusion Criteria (Both Cohorts)\n\n* Patient with acute GVHD \\> grade 2 or moderate or extensive chronic GVHD at the time of CTL infusion.\n* Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of CTL infusion.\n* Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion.\n* Patient with poor performance status determined by Karnofksy (patients \\> 16 yrs) or Lansky (patients \\\u003C 16 years) score \\\u003C 30%.\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory ADV or CMV infections.\n* Any known medical condition which cold compromise participation in the study according to investigators assessment.\n* Known AIDS or uncontrolled HIV infection\n* Known hypersensitivity to iron dextran\n* Encephalitis and\u002For retinitis","1 Day","30 Years",{"count":204,"type":20},69,[206],"PHASE3","Patients with refractory ADV or CMV infection post allogeneic stem cell transplant will be randomized to either Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) plus standard of care (SOC) vs SOC alone.",[209,210,211,28,27],"CMV","AdV Infection","AdV Reactivation","NOT_YET_RECRUITING","2025-11-06",{"date":215,"type":37},"2025-11-10",{"date":217,"type":20},"2026-12-01",{"date":219,"type":20},"2032-12-01",{"name":221,"class":44},"New York Medical College",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":229,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100585956","phase-1-viral-specific-t-lymphocytes-to-treat-infection-with-adenovirus-cytomegalovirus-or-epstein-barr-virus-in-patients-with-compromised-immunity-100585956","NCT06909110","Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With Compromised Immunity","Viral Specific T-Lymphocytes by Cytokine Capture System (CCS) to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus After Hematopoietic Cell Transplantation or Solid Organ Transplantation and in Patients With Compromised Immunity","Patient Inclusion Criteria\n\n1. Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For patients ≥ 7 years of age who are developmentally able, assent or affirmation will be obtained, if feasible.\n2. Male or female, 1 month through 65 years old, inclusive, at the time of informed consent.\n3. Prior allogeneic hematopoietic stem cell transplant, AND\u002FOR prior solid organ transplant (liver, kidney, lung and\u002For heart, intestinal, pancreatic, and\u002For multivisceral), AND\u002FOR diagnosis of primary immunodeficiency AND\u002FOR current\u002Frecent administration of immunosuppressive therapy for cancer or autoimmune disease.\n4. If receiving steroids, must be able to taper dose to less than 1 mg\u002Fkg\u002Fday prednisone (or equivalent) prior to cellular infusion.\n5. Negative pregnancy test for females ≥10 years old or who have reached menarche, unless surgically sterilized or post-menopausal.\n6. Diagnosis of Adenovirus, CMV, or EBV infection, persistent despite standard therapy.\n\nA. Adenovirus Infection or Disease (at minimum, one of the below sub-criteria must be met):\n\n1. Active adenovirus infection: (i.e. gastroenteritis, pneumonia, hemorrhagic cystitis, hepatitis, pancreatitis, meningitis) defined as the demonstration of adenovirus by biopsy specimen from affected site(s) (by culture or histology), or the detection of adenovirus by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents)\n2. Refractory adenoviremia: defined as DNAemia ≥1000 copies\u002FmL or \\\u003C1 log decrease after at least 2 weeks of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents)\n3. Intolerance of or contraindication to antiviral medications.\n\nB. CMV Infection or Disease (at minimum, one of the below sub-criteria must be met):\n\n1. Active CMV infection: (i.e. pneumonia, meningitis, retinitis, hepatitis, hemorrhagic cystitis, and\u002For gastroenteritis) defined as the demonstration of CMV by biopsy specimen from affected site(s) (by culture or histology) or the detection of CMV by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents)\n2. Refractory CMV viremia: defined as the continued presence of DNAemia, with ≥1,000 IU\u002FmL or \\\u003C1 log decrease after at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents)\n3. Intolerance of or contraindication to antiviral medications.\n\nC. EBV Infection or Disease (at minimum, one of the below sub-criteria must be met):\n\n1. EBV DNAemia ≥1000 IU\u002FmL, persistent despite 2 doses of rituximab,\n2. Biopsy proven lymphoma or lymphoproliferative disease with EBV genomes detected in tumor cells by immunocytochemistry (i.e. EBER positive) or in situ PCR,\n3. Clinical or imaging findings consistent with EBV lymphoma or lymphoproliferation with current or recent elevated EBV viral load in peripheral blood in a patient where biopsy is deemed too high risk,\n4. Failure of antiviral therapy, as determined by one of the two bullets below after two weeks of anti-CD20 targeted therapy such as rituximab, i. There was an increase or less than 50% response at sites of lymphoma disease or lymphoproliferation.\n\n   ii. There was a rise or a fall of less than 50% in EBV viral load in peripheral blood.\n5. Intolerance or contraindication to rituximab.\n\nPatient Exclusion Criteria:\n\n1. Received ATG or Alemtuzumab within 21 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by \\\u003C10 CD3+ T cells\u002FuL (in unique situations, plasmapheresis may be considered).\n2. Active acute GVHD grades II-IV.\n3. Active severe chronic GVHD.\n4. Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 21 days of planned viral-specific T cell infusion. Subjects receiving a fraction of an umbilical cord blood within 21 days of the viral-specific T cell infusion will not be excluded.\n5. Active and uncontrolled relapse of malignancy (other than EBV+ post-transplant lymphoproliferative disorder or lymphoma).\n6. Anticipated initiation of new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion.\n7. Patients who are pregnant or lactating.\n8. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, or concomitant medications, which, in the opinion of the investigator, may pose additional risks to participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.\n\nDonor Inclusion Criteria\n\n1. Age ≥ 12\\*\n2. Able to understand and sign the consent\u002Fassent to the procedure\n3. Partial (2\u002F6 or more) HLA match to the recipient\n4. A pediatric donor could be selected as a donor only if a suitable adult donor is not available (as attested by the research team) or is ineligible according to FACT requirements. For pediatric donors:\n\n   * Related to the recipient\n   * Apheresis does not need a blood prime before the procedure\n   * Adequate peripheral venous access\n   * Explicit evaluation of the donors' willingness to donate cells, as attested by the research team\n   * Must have understanding that they are helping their ill relative, as attested by the research team\n   * Will gain emotional\u002Fpsychological benefit from their ability to help and want to donate for a relative, as attested by the research team\n   * Inclusion of minor donors that are not relatives of the recipient will need to be evaluated on a case-by-case basis for the IRB to evaluate the potential benefit to these participants (whether they will receive an emotional and psychological boost from helping the recipient) \\*If the only suitable donor is less than 12 years old, a single patient exception to this inclusion criteria will be submitted and approved by the IRB before obtaining the donor's assent and their LAR consent.\n\nDonor Exclusion Criteria\n\n1. Donor is pregnant\n2. Donor is HIV positive\n3. Donor is positive for hepatitis B and\u002For hepatitis C\n4. Deemed to be a high-risk donor based on responses to donor risk questionnaire\n5. Deemed high risk due to preexisting medical condition or abnormal lab results","1 Month","65 Years",{"count":232,"type":20},25,[23,85],"The primary purpose of this phase I\u002FII study is to evaluate whether partially matched, ≥2\u002F6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV, and EBV, in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus, CMV, and EBV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. In this trial, we will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and\u002For SOT recipients, and\u002For patients with compromised immunity who have adenovirus, CMV, or EBV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.",[28,27,26],[237,28,63,238,239,240],"Cytokine Capture System","Epstein-Barr Virus","Hematopoietic Cell Transplant","Solid Organ Transplant","2025-08-08",{"date":243,"type":37},"2025-08-14",{"date":245,"type":37},"2025-04-30",{"date":247,"type":20},"2032-01-01",{"name":249,"class":44},"Jessie L. Alexander",3,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":229,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":260,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100306238","phase-2-adenovirus-specific-cytotoxic-t-lymphocytes-for-refractory-adenovirus-infection-100306238","NCT03266627","Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection","A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection With Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients","1. Patients with Adenovirus infections post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with:\n\n   * Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and\u002For\n   * clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis AND\u002FOR\n   * Medical intolerance to anti-viral therapies including:\n\n     * grade 2 renal insufficiency secondary to cidofovir Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.\n\n   Performance Status \\> 30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 yrs) Age: 0.1 to 79 years\n\n   Females of childbearing potential with a negative urine pregnancy test\n2. Donor Eligibility Related donor available with a T-cell response to the viral MACS® GMP PepTivator antigen(s) of adenovirus.\n\n   a. Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor \\> 1 HLA A, B, DR match to recipient) with a T-cell response at least to the viral MACS® GMP PepTivator antigen(s) of adenovirus.\n\n   AND Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).\n\n   AND Obtained informed consents by donor or donor legally authorized representative prior to donor collection.\n3. Patient exclusion criteria:\n\nA patient meeting any of the following criteria is not eligible for the present study:\n\n. Patient 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 adenovirus infection(s) 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\n\n\\-","79 Years",{"count":57,"type":20},[85],"Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.\n\nFunding Source: FDA OOPD",[28,263],"Primary Immune Deficiency Disorder",[265,266,267],"adenovirus","primary immune deficiency disorder","cytotoxic t-lymphocytes","2025-08-07",{"date":241,"type":37},{"date":271,"type":37},"2018-11-01",{"date":273,"type":20},"2027-12-31",{"name":221,"class":44},10,{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":283,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":21,"phases":287,"briefSummary":24,"conditions":288,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":45},"100587323","phase-1-r-mvst-cells-for-treatment-of-viral-infections-in-children-and-young-adults-100587323","NCT06926894","R-MVST Cells for Treatment of Viral Infections in Children and Young Adults","Single Center Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells for Immunodeficient Children and Young Adults","Inclusion Criteria:\n\n* Children and young adults (3 months to \\\u003C26 years) of all ethnic groups will be eligible for the treatment\n* Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and\u002For infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.\n* Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections\u002Freactivations will be eligible as long as at least one of those viral infections meet the criterium of \"refractory\".\n\nExclusion Criteria:\n\n* Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. 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* Patients who receive corticosteroids at ≥ 0.5mg\u002Fkg prednisone or equivalent.\n* Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosuppressive monoclonal antibodies in the last 28 days.\n* Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.\n* Patients who received extracorporeal photopheresis within the last 28 days.\n* Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.\n* Received donor lymphocyte infusion in last 28 days.\n* Evidence of GVHD ≥ grade 2\n* Evidence of biopsy-proven acute rejection in SOT recipients\n* Active and uncontrolled relapse of malignancy\n* Patients who are pregnant, or breastfeeding.\n* Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.\n* Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.\n* Unable or unwilling to receive infusions at Morgan Stanley Children's Hospital.","3 Months","26 Years",{"count":286,"type":20},18,[23],[238,27,28,29,289],"Immune Deficiency","2025-07-29",{"date":292,"type":37},"2025-07-31",{"date":294,"type":37},"2025-04-20",{"date":296,"type":20},"2030-12",{"name":43,"class":44}]