[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02479698":3,"trial-entities:NCT02479698":142,"trial-summary:NCT02479698":148},{"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":27,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":49,"secondary_outcomes":62,"sex":69,"minimum_age":70,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":100,"locations":104,"central_contacts":123,"overall_officials":125,"references":127,"see_also_links":138},"NCT02479698","2014-0279","Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and\u002For JC Virus","Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection","RECRUITING","2027-07-31","2026-08","2026-08-21","2015-07-23","M.D. Anderson Cancer Center","OTHER",false,"This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and\u002For JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and\u002For JC virus.","PRIMARY OBJECTIVE:\n\nI. To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched BK specific cytotoxic T lymphocyte (CTL) lines (BK-CTLs) generated by ex vivo expansion to mediate antiviral activity in patients with any type of malignancies, and\u002For HIV\u002FAIDs, and\u002For history of solid organ transplant with BK and JC infections.,\n\nSECONDARY OBJECTIVE:\n\nI. To assess the persistence of the administered BK-CTLs generated by ex vivo expansion in immunocompromised patients, patients with any type of malignancies, or HIV\u002FAIDs, and\u002For history of solid organ transplant with BK and JC infections.",[19,20,21,22,23,24,25,26],"Acquired Immunodeficiency Syndrome","BK Virus Infection","Human Immunodeficiency Virus","JC Virus Infection","Malignant Neoplasm","Merkel Cell Carcinoma","Merkel Cell Polyomavirus Infection","Viral Encephalitis",[],"INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},100,"ESTIMATED",[36,45],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"BIOLOGICAL","Allogeneic BK-specific Cytotoxic T-lymphocytes","Given IV",[41],"Treatment (BK-specific cytotoxic T lymphocytes)",[43,44],"Allogeneic BK-CTLs","Allogeneic BK-specific CTLs",{"type":14,"name":46,"description":47,"armGroupLabels":48},"Laboratory Biomarker Analysis","Correlative studies",[41],[50,54,58],{"measure":51,"description":52,"timeFrame":53},"Response, defined as response (R) = (best response [R1] or second best response [R2])","The method of Thall et al will be used to monitor the probabilities of response.","Up to 56 days",{"measure":55,"description":56,"timeFrame":57},"Incidence of acute graft-versus-host disease (GVHD)","The method of Thall et al will be used to monitor the probabilities of grade 3 or 4 GVHD.","Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs)",{"measure":59,"description":60,"timeFrame":61},"Incidence of adverse events","Will be continuously monitored.","Up to day 100",[63,67],{"measure":64,"description":65,"timeFrame":66},"Overall survival","Each outcome will be evaluated by tabulation and by fitting a Bayesian statistical regression model for binary outcomes as a function of covar. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.","Up to 12 months",{"measure":68,"description":65,"timeFrame":66},"Glomerular filtration rate","ALL",null,{"inclusion":72,"exclusion":92,"raw_text":99},[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91],"Patients ≥ 2 years.","English and non-English speaking patients are eligible.","Immunocompromised patients including but not limited to those with any type of malignancy, HIV\u002FAIDS, or history of solid organ transplant","Non-immunocompromised patients with PML\u002FJC virus encephalitis","Microscopic or greater hematuria urine or blood PCR positive for BK virus","Biopsy proven BK nephritis and urine or blood PCR positive for BK virus disease and\u002For polyomavirus.","Definite or probable PML\u002FJC viral encephalitis (see Appendix C)","JC end-organ disease","Receiving \\> 6 mg \u002F day of prednisone or equivalent at the time of enrollment.","Patients with BK virus hemorrhagic cystitis, who are receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion.","Patients with JCV encephalitis \u002F PML may be receiving pembrolizumab.","Written informed consent and\u002For signed assent from patient, parent or guardian.","Patients with cognitive impairments are eligible.","A negative pregnancy test in female patients of childbearing potential. Childbearing potential is defined as pre-menopausal, post-menopausal for \\\u003C 1 year, and not having undergone surgical sterilization.","Women of childbearing potential must be willing to use an effective contraceptive measure while on study.","Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI.","Patients with bacterial infections must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.","Patients with fungal infections patients must be receiving definitive systemic anti fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.","Patients may be re-enrolled in the protocol if the BK or JC virus infection recurs, so long as they meet all the other eligibility criteria at the time of re-enrollment.",[93,94,95,96,97,98],"Patients receiving \\> 6 mg \u002F day of prednisone or equivalent at time of","Patients who have received ATG within 14 days of enrollment","Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment.","Patients who have received alemtuzumab within 28 days of enrollment.","Patients with other uncontrolled infections (including HIV\u002FAIDS). Uncontrolled infection is defined as the presence of 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 uncontrolled infection.","Patients with active acute GVHD grades II-IV.","Inclusion Criteria:\n\n* Patients ≥ 2 years.\n* English and non-English speaking patients are eligible.\n* Immunocompromised patients including but not limited to those with any type of malignancy, HIV\u002FAIDS, or history of solid organ transplant\n* Non-immunocompromised patients with PML\u002FJC virus encephalitis\n* Microscopic or greater hematuria urine or blood PCR positive for BK virus\n* Biopsy proven BK nephritis and urine or blood PCR positive for BK virus disease and\u002For polyomavirus.\n* Definite or probable PML\u002FJC viral encephalitis (see Appendix C)\n* JC end-organ disease\n* Receiving \\> 6 mg \u002F day of prednisone or equivalent at the time of enrollment.\n* Patients with BK virus hemorrhagic cystitis, who are receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion.\n* Patients with JCV encephalitis \u002F PML may be receiving pembrolizumab.\n* Written informed consent and\u002For signed assent from patient, parent or guardian.\n* Patients with cognitive impairments are eligible.\n* A negative pregnancy test in female patients of childbearing potential. Childbearing potential is defined as pre-menopausal, post-menopausal for \\\u003C 1 year, and not having undergone surgical sterilization.\n* Women of childbearing potential must be willing to use an effective contraceptive measure while on study.\n* Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI.\n* Patients with bacterial infections must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.\n* Patients with 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 may be re-enrolled in the protocol if the BK or JC virus infection recurs, so long as they meet all the other eligibility criteria at the time of re-enrollment.\n\nExclusion Criteria:\n\n* Patients receiving \\> 6 mg \u002F day of prednisone or equivalent at time of\n* Patients who have received ATG within 14 days of enrollment\n* Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment.\n* Patients who have received alemtuzumab within 28 days of enrollment.\n* Patients with other uncontrolled infections (including HIV\u002FAIDS). Uncontrolled infection is defined as the presence of 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 uncontrolled infection.\n* Patients with active acute GVHD grades II-IV.",[101,102,103],"CHILD","ADULT","OLDER_ADULT",[105],{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":120},"M D Anderson Cancer Center","Houston","Texas","77030","United States",[112,117],{"name":113,"role":114,"phone":115,"email":116},"George Chen, MD","CONTACT","713-792-3630","GLChen1@mdanderson.org",{"name":118,"role":119},"George Chen","PRINCIPAL_INVESTIGATOR",{"lat":121,"lon":122},29.76328,-95.36327,[124],{"name":113,"role":114,"phone":115,"email":116},[126],{"name":113,"affiliation":13,"role":119},[128,132,135],{"pmid":129,"type":130,"citation":131},"42402341","DERIVED","Olson A, Li Y, Marin D, Thall PF, Bassett RL, Barnett M, Basar R, Banerjee PP, Kleiman TA, Chen M, Rexer J, Wintermark M, Choi J, Learned K, Kaur I, Sylejmani M, Abueg G, Chemaly RF, Mulanovich V, Shrestha R, Uprety N, Castro KM, Daher M, Galvan IM, Washington D, Champlin RE, Shpall EJ, Rezvani K. Treatment of Progressive Multifocal Leukoencephalopathy with Third-Party Allogeneic BK Virus T Cells. Clin Infect Dis. 2026 Jul 6:ciag404. doi: 10.1093\u002Fcid\u002Fciag404. Online ahead of print.",{"pmid":133,"type":130,"citation":134},"33929874","Olson A, Lin R, Marin D, Rafei H, Bdaiwi MH, Thall PF, Basar R, Abudayyeh A, Banerjee P, Aung FM, Kaur I, Abueg G, Rao S, Chemaly R, Mulanovich V, Al-Atrash G, Alousi AM, Andersson BS, Anderlini P, Bashir Q, Castro KM, Daher M, Galvan IM, Hosing C, Im JS, Jones RB, Kebriaei P, Khouri I, Mehta R, Molldrem J, Nieto Y, Oran B, Popat U, Qazilbash M, Rondon G, Saini N, Spencer B, Srour S, Washington D, Barnett M, Champlin RE, Shpall EJ, Rezvani K. Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation. J Clin Oncol. 2021 Aug 20;39(24):2710-2719. doi: 10.1200\u002FJCO.20.02608. Epub 2021 Apr 30.",{"pmid":136,"type":130,"citation":137},"30304652","Muftuoglu M, Olson A, Marin D, Ahmed S, Mulanovich V, Tummala S, Chi TL, Ferrajoli A, Kaur I, Li L, Champlin R, Shpall EJ, Rezvani K. Allogeneic BK Virus-Specific T Cells for Progressive Multifocal Leukoencephalopathy. N Engl J Med. 2018 Oct 11;379(15):1443-1451. doi: 10.1056\u002FNEJMoa1801540.",[139],{"label":140,"url":141},"University of Texas MD Anderson Cancer Center Website","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":143,"biomarkers":144},[19,20,22,23,24,26],[145,146,147],"BK virus","JC virus","Merkel cell polyomavirus",{"nct_id":4,"found":149,"summary":150,"prompt_version":160},true,{"design":151,"status":152,"heading":153,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This is an interventional study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.","completed","Cytotoxic T Lymphocytes for Malignancies with BK and\u002For JC Virus","This study is looking at how well a treatment called allogeneic BK-specific Cytotoxic T-lymphocytes (special immune cells) works in people with cancer (malignancies) who also have BK and\u002For JC virus infections. These immune cells are grown in a lab from donated blood and are designed to fight viruses. Researchers want to see if these cells can effectively treat the infections and potentially help with the cancer. You might be able to join if you are at least 2 years old, are immunocompromised, have certain types of cancer, HIV\u002FAIDS, or a history of organ transplant. The study will measure how well the treatment works, any side effects, and how long the immune cells stay in your body.","After treatment, you would be followed up periodically for 12 months.",116,"You would receive allogeneic BK-specific Cytotoxic T-lymphocytes intravenously. If you respond well, you might receive up to 7 additional infusions.","Not stated in the trial record.",[38],"v2"]