[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epstein-barr-virus-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epstein-barr-virus-infections":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,75,105,128,193,216],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100305619","phase-2-nivolumab-in-epstein-barr-virus-ebv-positive-lymphoproliferative-disorders-and-ebv-positive-non-hodgkinlymphomas-100305619",false,"NCT03258567","Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas","Phase 2 Trial of Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-Hodgkin Lymphomas","* INCLUSION CRITERIA:\n* Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, NCI.\n\n  * EBV-positive LPD. Subjects may be previously untreated or relapsed from prior therapy.\n\n    1. Lymphomatoid granulomatosis (LYG), grades I-II\n    2. Chronic active EBV disease (CAEBV) of B-cells or T-cells\n    3. EBV-positive post-transplantation lymphoproliferative disorder (PTLD)\n\n       NOTE: PTLD after solid organ transplantation is excluded. Patients who, at the discretion of the investigator, need urgent therapy with standard agents will not be eligible.\n  * EBV-positive B-cell NHL. Subjects must have relapsed from previous treatment with an anthracycline and rituximab-based regimen or be considered not eligible for the same.\n\n    1. Lymphomatoid granulomatosis (LYG), grade III\n    2. EBV-positive immunodeficiency-associated diffuse large B-cell lymphoma (DLBCL)\n    3. EBV-positive DLBCL\n* Subjects must be at least 2 weeks from prior anti-lymphoma therapy (including radiation therapy)\n* Subjects must be at least 100 days from prior stem cell transplant (autologous or allogeneic) or Donor Lymphocyte Infusion (DLI)\n\n  * Age \\>=12 years\n  * Patients \\>= 12 and \\\u003C 18 years of age should weigh at least 40 kilograms (kg); there is no weight requirement for adult subjects.\n  * NOTE: If a pediatric patient is identified for possible enrollment who weighs less than 40 kg, the safety of the nivolumab dosing strategy used in this study must be discussed with the PI and manufacturer to confirm safety, and this discussion\u002Fapproval for enrollment documented in the medical record prior to declaring the pediatric patient eligible.\n* Adequate performance status as follows:\n\n  * Patients \\>= 16 years must have ECOG Performance Status 0-2 (Karnofsky \\>=60%)\n  * Pediatric patients \\\u003C 16 years must have Lansky play-performance of 60-100%\n* Subjects must have measurable or evaluable disease.\n* Subjects must have adequate organ and bone marrow reserve (unless disease-related) as defined below:\n\n  * absolute neutrophil count - \\>= 750\u002FmcL; \\>= 500\u002FmcL if impairment is due to LPD\u002FNHL\n  * platelets - \\>= 50,000\u002FmcL; \\>= 25,000\u002FmcL if impairment is due to LPD\u002FNHL (transfusions not permitted)\n  * Hemoglobin - \\>= 9g\u002FdL (transfusion permitted)\n  * total bilirubin - \\\u003C 3.0g\u002Fdl OR \\\u003C 5.0g\u002Fdl if Gilbert s syndrome or disease infiltration of the liver is present\n  * AST(SGOT)\u002FALT(SGPT) - \\\u003C= 3 X institutional upper limit of normal\n  * serum creatinine OR creatinine clearance - Adults: \\\u003C= 1.5 mg\u002FdL; Minors: serum Cr \\\u003C= age-adjusted normal OR \\>= 40 ml\u002Fmin\u002F1.73m\\^2\n\nAge(Years) 12-15: Maximum Serum Creatinine (mg\u002Fdl): 1.2\n\nAge(Years) \\> 15: Maximum Serum Creatinine (mg\u002Fdl): 1.5\n\n* A formalin fixed tissue block or at least 15 slides of tumor sample (archival or fresh) must be available for performance of correlative studies. NOTE: Patient must be willing to have a pre-treatment tumor biopsy if adequate archival tissue is not available.\n* The toxicity profile of nivolumab in patients with disease involvement of the central nervous system (CNS) is unknown. For this reason, we will introduce early stopping rules.\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, the following measures apply:\n\n  * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) during screening and within 48 hours prior to the first dose of nivolumab.\n  * WOCBP and men who are sexually active with WOCBP must use adequate contraception (e.g., hormonal or 2 barrier methods with a failure rate of less than 1% per year or abstinence) prior to study entry and throughout study drug administration. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.\n  * Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception).\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and who is not postmenopausal. Post menopause is defined as:\n\n    1. Amenorrhea \\>= 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL or\n    2. Women with irregular menstrual periods and a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL or NOTE: FSH level testing is not required for women \\>= 62 years old with amenorrhea of \\>= 1 year\n    3. Women on hormone replacement therapy (HRT)\n* Pregnant women are excluded from this study because nivolumab is an IgG monoclonal antibody with the potential for teratogenic or abortifacient effects.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab, nursing should be discontinued if the mother is treated with nivolumab.\n* Ability of subject or Legally Authorized Representative (LAR) to understand and sign the written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Subjects who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.\n* Subjects with second malignancies requiring active systemic therapy are excluded. Subjects with second malignancies not requiring active systemic therapy or pre-malignant conditions such as monoclonal B-cell lymphocytosis (MBL) or monoclonal gammopathy of undetermined significance (MGUS) may be eligible.\n* Subjects with any condition or autoimmune disease that requires systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted.\n* Subjects with active graft-vs-host disease (GVHD) requiring steroids or other immunosuppressive agents; history of \\>=grade II acute GVHD or extensive chronic GVHD.\n* Subjects who have had solid organ transplant.\n* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody.\n* Non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration.\n* A serious uncontrolled medical condition requiring therapy.\n* Seizures disorder not controlled by anti-seizure medications.\n* Subjects with CNS involvement may be included on the study as long as they have not had any seizure activity in past 4 weeks.\n* Hepatitis B virus surface antigen positive.\n* Active Hepatitis C infection with a positive PCR; subjects who are Hepatitis C antibody positive and PCR negative may be eligible. In these cases, the subjects will be monitored via HCV PCR throughout the study.\n* History of anaphylactic reaction to monoclonal antibody therapy.\n* HIV positive subjects are excluded because the function of their T-cell immune responses is impaired.","ALL","12 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\nThe drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments.\n\nObjectives:\n\nTo see if Nivolumab slows the growth of some types of cancer or stops them from getting worse. To test the safety of the drug.\n\nEligibility:\n\nPeople 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders or EBV-positive non-Hodgkin lymphomas with no standard therapy\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nCAT scan of the chest, abdomen, and pelvis\n\nTumor and bone marrow biopsies (sample taken)\n\nMagnetic resonance imaging scan of the brain\n\nLumbar puncture (also known as spinal tap)\n\nPositron emission tomography\u002Fcomputed tomography scan with a radioactive tracer\n\nEvery 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also have:\n\nPhysical exam\n\nBlood and pregnancy tests\n\nReview of side effects and medications\n\nDuring the study, participants will repeat most of the screening tests. They may also have other biopsies.\n\nAfter stopping treatment, participants will have a visit every 3 months for 1 year. Then they will have a visit every 6 months for years 2-5, and then once a year. They will have a physical exam and blood tests.\n\n...",[26,27,28,29],"Epstein-Barr Virus Infections","Lymphoma","Lymphoproliferative Disorder","Disorders, Lymphoproliferative",[31],"Monoclonal Antibody","RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2018-04-26",{"date":40,"type":20},"2031-06-01",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100453357","phase-1-r-mvst-cells-for-treatment-of-viral-infections-100453357","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).","18 Years",{"count":54,"type":20},36,[56],"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.",[26,59,60,61],"Cytomegalovirus Infections","Adenovirus","BK Virus Infection",[63,64],"Rapidly generated virus specific T cells (R-MVST)","Refractory viral reactivation","2026-06-08",{"date":67,"type":36},"2026-06-10",{"date":69,"type":36},"2022-05-03",{"date":71,"type":20},"2028-06",{"name":73,"class":74},"Columbia University","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"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":85,"type":20},25,[56,23],"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.",[60,59,26],[90,60,91,92,93,94],"Cytokine Capture System","Cytomegalovirus","Epstein-Barr Virus","Hematopoietic Cell Transplant","Solid Organ Transplant","2025-08-08",{"date":97,"type":36},"2025-08-14",{"date":99,"type":36},"2025-04-30",{"date":101,"type":20},"2032-01-01",{"name":103,"class":74},"Jessie L. Alexander",3,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100306240","phase-2-ebv-specific-cytotoxic-t-lymphocytes-ctls-for-refractory-ebv-infection-100306240","NCT03266653","EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection","A Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection With Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients","1\\. Patients with Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with:\n\n* Increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and\u002For\n* progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly AND\u002FOR\n* Medical intolerance to anti-viral therapies including:\n* intolerance to rituximab Consent: 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\n2 Donor Eligibility 5.2.1 Related donor available with a T-cell response to the EBV MACS® GMP PepTivator antigen(s) causing the therapy-refractory EBV infection.\n\na. Third Party Related 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 EBV and\u002For a T-cell response at least to the viral MACS® GMP PepTivator EBV Select (containing among other antigens, NA-1, LMP2A and BZLF-1).\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 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 EBV infection 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","79 Years",{"count":114,"type":20},20,[23],"Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.\n\nFunding Source: FDA OOPD",[26,118],"Primary Immune Deficiency Disorder","2025-08-07",{"date":95,"type":36},{"date":122,"type":36},"2020-07-07",{"date":124,"type":20},"2027-12-31",{"name":126,"class":74},"New York Medical College",8,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":152,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":192},"100484789","phase-1-a-study-of-a-selective-t-cell-receptor-tcr-targeting-bifunctional-antibody-fusion-molecule-star0602-in-participants-with-advanced-solid-tumors-100484789","NCT05592626","A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)","START-001","Inclusion Criteria:\n\n1. Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Subjects should not have received more than three lines of prior therapies for their advanced or metastatic diseases.\n2. For Phase 1, participants must have one of the following solid tumors:\n\n   1. High mutational burden (TMB-H)\n   2. Microsatellite Instability (MSI-H)\u002FDNA mismatch repair (dMMR)\n   3. Virally associated tumors\n3. For Phase 2, participants must have one of the following solid tumors:\n\n   1. TMB-H\n   2. MSI-H\u002FdMMR\n   3. CRC (both Ras wild type and mutant)\n   4. Virally associated tumors\n   5. Metastatic triple negative breast cancer\n   6. Platinum-resistant epithelial ovarian cancer\n   7. Metastatic castration-resistance prostate cancer\n   8. Primary stage IV or recurrent non-small cell lung cancer\n   9. Immunogenic solid tumors\n\n   (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)\n4. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n\n   * No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \\> 10 mg prednisone\u002Fday or equivalent);\n   * No concurrent leptomeningeal disease or cord compression.\n\nExclusion Criteria:\n\n1. Participants with a history of known autoimmune disease with exceptions of:\n\n   * Vitiligo;\n   * Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;\n   * History of Graves' disease, now euthyroid for \\> 4 weeks;\n   * Hypothyroidism managed by thyroid replacement;\n   * Alopecia;\n   * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.\n   * Adrenal insufficiency well controlled on replacement therapy.\n2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.\n3. Unhealed wounds from surgery or injury.\n4. Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.\n5. Clinically significant cardiovascular\u002Fvascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises\n6. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.\n7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.\n8. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.\n9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.\n10. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).\n11. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.",{"count":137,"type":20},365,[56,23],"This is an open label, multicenter, phase 1\u002F2 study to assess the safety\u002Ftolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.",[141,142,143,144,145,146,26,147,148,149,150,151],"Advanced Solid Tumors","Genital Neoplasm, Female","Urogenital Neoplasms","Lung Neoplasm","Neoplasms by Site","Papillomavirus Infection","Carcinoma","Neoplasms","Vulvar Neoplasms","Vulvar Diseases","Abdominal Neoplasm",[141,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181],"STAR0602","Intravenous","Antineoplastic Agents","T Cell Receptor-targeting","Bifunctional Antibody-Fusion","Specific T Cell Activator","Tumor Mutational Burden (TMB) High","Microsatellite Instability (MSI) High","Virally Associated Malignancies","Checkpoint Inhibitor Resistance","Immunotherapy","Immune Checkpoint Inhibitor Resistance","Head and Neck Cancer","Nasopharyngeal Cancer","Non-small Cell Lung Cancer","Small Cell Lung Cancer","Biliary Cancer","Melanoma","Merkel Cell Carcinoma","Skin Squamous Cell Carcinoma","Skin Basal Cell Carcinoma","Endometrial Cancer","Colorectal Cancer","Small Bowel Cancer","Cervical Cancer","Gastrointestinal Neoplasms","Gastric Cancer","Esophageal Cancer","Bladder Cancer","2025-07-07",{"date":184,"type":36},"2025-07-09",{"date":186,"type":36},"2023-01-04",{"date":188,"type":20},"2026-10",{"name":190,"class":191},"Marengo Therapeutics, Inc.","INDUSTRY",32,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":44},"100438454","phase-4-evaluation-of-the-efficacy-of-a-treatment-by-one-single-dose-of-rituximab-375mgm2--in-the-prevention-of-the-epstein-barr-virus-ebv-primary-infection-and-post-transplant-lymphoproliferative-disorder-in-adult-ebv-seronegative-patients-who-received-an-ebv-seropositive-kidney-allograft-100438454","NCT04989491","Evaluation of the Efficacy of a Treatment by One Single Dose of Rituximab (375mg\u002Fm2 ) in the Prevention of the Epstein Barr Virus (EBV) Primary Infection and Post-transplant Lymphoproliferative Disorder in Adult EBV Seronegative Patients Who Received an EBV Seropositive Kidney Allograft","Multicenter Randomized Two Arms Study Evaluating the Efficacy of Prophylactic Rituximab in Adult EBV Negative Kidney Transplant Recipients on Incidence of EBV Primary Infection and Post-transplant Lymphoproliferative Disorders","REPLY","Inclusion Criteria:\n\n* Adult patients (age ≥18 years at transplantation)\n* Kidney and kidney pancreas simultaneous transplantation\n* EBV seronegative patients (IgG anti EBNA, IgG anti VCA and IgM anti VCA negative) (from 6 months before transplantation to the day of transplantation, included)\n* Patient who have given written informed consent\n* Negative pregnancy test and use of contraception during all the study\n* EBV positive donor\n* Patient affiliated to a social security scheme\n\nExclusion criteria:\n\n* Patient with known HBV active infection\n* Allergy to Rituximab\n* Severe Immune deficiency\n* Severe cardiac insufficiency\n* Pregnant or lactating women\n* Women of child bearing potential unless they are using a birth control method\n* Patient under judicial protection or under guardianship\n* Patient currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criterion\n* Any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, is incompatible with the participation in the study\n* Unlikely to comply with the visits scheduled in the protocol.\n\nExclusion Criteria:\n\n\\-",{"count":202,"type":20},120,[204],"PHASE4","Epstein Barr virus infects over 90% of human population and persists during lifetime. After infecting B lymphocytes, EBV remains latent in memory B cells. In immunocompromised patients, primary infection could lead to an uncontrolled EBV infected B cells proliferation because of impaired T cell specific cytotoxicity. The latent EBV infection is characterized by expression of restricted latent gene products, which drive cell proliferation and progression to PTLD. As a consequence, EBV seronegativity and EBV mismatch are major risk factors for developing PTLD. The investigators reported in a previous work from the French Registry that the incidence of PTLD was multiplied by ten in adult EBV negative kidney transplant recipients. Moreover, even if the event is relatively rare after transplantation, the prognosis is severe with high morbidity and an overall mortality rate around 50%.\n\nNowadays, few and inconsistent data exist regarding beneficial preventing strategies like antiviral therapy, reduction of immunosuppression or immunoglobulin infusion in this high-risk population of EBV negative recipients. Therefore, an efficient and safe preventive treatment is still lacking to decrease PTLD incidence.\n\nRituximab, has been already proposed in stem cell transplant recipients as a preemptive therapy in patients with a persistent EBV viremia independently of their EBV status. A pilot study was performed in EBV negative kidney transplant recipients but in a very small population. Schachtner60 reported the cases of 5 EBV negative recipients receiving kidney from EBV positive donors after a treatment with Rituximab. Only 2 patients showed a seroconversion and no patients developed neither a viremia nor a PTLD after 49 months of follow-up.\n\nThe main objective of the investigators study is to evaluate the efficacy of early infusion of Rituximab in the prevention of EBV primary infection and post-transplant lymphoproliferative disorder (PTLD) occurrence in adult EBV negative kidney transplant recipients transplanted with an EBV positive donor.",[26],"2024-08-16",{"date":209,"type":36},"2024-08-19",{"date":211,"type":36},"2021-12-01",{"date":213,"type":20},"2029-12-01",{"name":215,"class":74},"University Hospital, Strasbourg, France",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":223,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":227,"phases":4,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":44},"100558674","evaluation-of-cmvebv-cmi-in-haploid-hsct-100558674","NCT06554197","Evaluation of CMV\u002FEBV-CMI in Haploid HSCT","Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. All patients were diagnosed with hemopathy.\n2. All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.\n3. All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.\n\nExclusion Criteria:\n\nPatients with any conditions not suitable for the trial (investigators' decision).","16 Years","60 Years",{"count":226,"type":20},60,"OBSERVATIONAL","The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .",[230,59,26],"Hematopoietic Stem Cell Transplantation","2024-08-13",{"date":233,"type":36},"2024-08-15",{"date":231,"type":20},{"date":236,"type":20},"2026-07-31",{"name":238,"class":74},"The First Affiliated Hospital of Soochow University"]