[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"LucasBio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,89],{"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":27,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100645072","evaluation-of-safety-and-efficacy-of-autologous-lb-dtk-cmv-in-patients-with-antiviral-resistant-and-refractory-cytomegalovirus-retinitis-100645072",false,"NCT07679412","Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.","An Exploratory Clinical Study of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.","Inclusion Criteria:\n\n1. Patients aged 19 years or older who have been diagnosed with CMV retinitis and have undergone hematopoietic stem cell transplantation or solid organ transplantation for the treatment of hematologic malignancies, or have received high-dose immunosuppressive therapy for the treatment of autoimmune diseases, and who meet at least one of the following criteria:\n\n   * Patients with persistent or progressive CMV retinitis despite systemic antiviral therapy or intravitreal antiviral treatment.\n   * Patients who have showed persistent CMV viremia despite systemic antiviral therapy or developed new CMV retinitis.\n   * Patients with CMV UL54 or UL97 mutations associated with antiviral resistance.\n   * Patients with adverse effects or toxicities limiting the administration of more than one systemic antiviral drug.\n2. Patients who are pregnant and able to reduce their steroid dosage to 0.5mg\u002Fkg\u002Fday of Prednisolone (or an equivalent dose) or less.\n3. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.\n4. Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.\n5. Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc).\n\nExclusion Criteria:\n\n1. Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.\n2. Individuals who meet any of the following criteria at the time of screening:\n\n   * Uncontrolled hypertension\n\n     * Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.\n   * Uncontrolled severe diabetes: Severe diabetes is defined as follows:\n\n     * Severe hyperglycemia with HbA1C ≥ 10.0%\n     * Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks.\n     * Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose \\\u003C54 mg\u002FdL) accompanied by seizures and loss of consciousness.\n   * Other viral infections\n\n     * Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)\n     * However, patients who are tested negative for HBsAg and positive for Anti-HBcAb are not subject to this exclusion criterion.\n   * Tuberculosis\n   * Syphilis\n   * Moderate or severe liver damage\n\n     * Aspartate aminotransferase (AST) or Alanin aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN)\n   * Chronic kidney disease\n\n     * eGFR \\\u003C 30mL\u002Fmin\u002F1.73m\\^2\n   * Other uncontrolled infections. However, the following cases are considered controlled infections and do not meet the exclusion criteria:\n\n     * Bacterial infection: Patients must be undergoing definitive antibiotic treatment for the infection and must have shown no signs of progression of the infection for 72 hours prior to enrollment in this clinical study.\n     * Fungal infection: Patients must be receiving systemic antifungal therapy and must have shown no signs of infection progression for 1 week prior to enrollment in this clinical study.\n3. Patients who have received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.\n4. Patients with active malignant tumor or uncontrolled recurrence.\n5. Patients with uncontrolled ophthalmic diseases other than CMV retinitis.\n6. Female subjects who are pregnant, breastfeeding, of childbearing potential, or not using appropriate contraceptive methods.\n7. Patients with a life expectancy of less than 24 hours at the time of the screening visit.\n8. Patients who have received an investigational product from another clinical study within 24 weeks prior to administration of the investigational product in this study.\n9. Patients deemed ineligible for participation in this clinical study by the investigator.","ALL","19 Years",{"count":19,"type":20},5,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this exploratory clinical study is to evaluate the safety and efficacy of Cytomegalovirus-Specific T cells (LB-DTK-CMV) to treat patients diagnosed with antiviral-resistant and refractory cytomegalovirus retinitis. The main questions it aims to answer are:\n\n* What adverse events occur after the infusion of LB-DTK-CMV?\n* What is the duration of efficacy following treatment?\n* Is there a clinically significant reduction in CMV viral load in plasma and aqueous humor after the infusion?\n* Is there a clinically significant improvement in clinical symptoms after the infusion?\n\nParticipants will:\n\n* Receive two infusions of LB-DTK-CMV at 2x10\\^7cells\u002Fm\\^2 at two-week intervals beginning at the baseline visit (Cycle 1).\n* Take a three-week resting period following completion of Cycle 1.\n* Receive two infusions of LB-DTK-CMV at 2x10\\^7cells\u002Fm\\^2 at two-week intervals beginning three weeks after the last dose of Cycle 1 (Cycle 2).",[26],"CMV Retinitis",[28,29,30,31,32,33,34,35,36,37,38],"CMV","Retinitis","Virus-specific T cells","Antiviral-resistant CMV","Refractory CMV","Hematopoietic Stem Cell Transplantation","Solid Organ Transplantation","Hematologic malignancy","Autoimmune Disease","Immunosuppressants","Immunosuppressive drugs","RECRUITING","2026-06-25",{"date":42,"type":43},"2026-07-01","ACTUAL",{"date":45,"type":43},"2026-04-27",{"date":47,"type":20},"2027-08-14",{"name":49,"class":50},"LucasBio","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":51},"100644480","phase-1-evaluation-of-the-safety-and-efficacy-of-lb-dtk-mv-in-patients-diagnosed-with-antiviral-resistant-cmv-bkv-or-ebv-infection-or-associated-diseases-following-anticancer-therapy-or-allogeneic-hematopoietic-stem-cell-transplantation-100644480","NCT07670468","Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.","A Single-Center, Open-Label, Phase 1\u002F2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n1. Patients aged 19 years or older who have undergone myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation using bone marrow, single or double umbilical cord blood, or peripheral blood stem cells (PBSCs). Or patients who have undergone any of the following anticancer treatments:\n\n   * CAR-T: Kymriah, Yescarta\n   * Bispecific Antibody: Glofitamab, Mosunetuzumab, Teclistamab, Elranatamab, etc\n2. Patients diagnosed with single or multiple, antiviral-resistant CMV, BKV, and\u002For EBV despite receiving standard treatment.\n3. Patients who are able to reduce their steroid dosage to 0.5mg\u002Fkg\u002Fday of Prednisolone (or an equivalent dose) or less.\n4. Patients with a hemoglobin level ≥8.0g\u002FdL.\n5. Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5x10\\^3\u002FμL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.\n6. Patients with peripheral oxygen saturation (SpO2) ≥90% on room air.\n7. Patients who have at least one MHC class I HLA allele that matches the investigational product.\n8. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.\n9. Female subjects or male subjects with female partners who agree to use the following contraceptive methods during the duration of this clinical trial and who meet the following criteria:\n\n   * Female participants or male participants with female partners who are postmenopausal (diagnosed with non-therapy-induced amenorrhea for 12 months or more or menopause)\n   * Female subjects or the female partners of male subjects who are surgically sterile (i.e., lacking ovaries and\u002For a uterus)\n   * Individuals who have agreed to strict abstinence during the clinical trial period \\[For female participants, intermittent abstinence (e.g., withdrawal during ovulation, the basal body temperature method, or withdrawal after ovulation) does not constitute agreement to abstinence\\]\n   * If the female subject or the female partner of a male subject is a woman of childbearing potential (WOCBP) who has not undergone sterilization, those who meet the following criteria:\n\n     * Hormonal contraceptives (implant, patch, oral)\n     * Intrauterine devices\n     * Dual barrier method (simultaneous use of the following two contraceptive methods: male condoms, female condoms, cervical caps, contraceptive diaphragms, contraceptive sponges)\n10. Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions.\n11. Individuals deemed suitable as trial subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).\n\nExclusion Criteria:\n\n1. Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.\n2. Individuals who meet any of the following criteria at the time of screening:\n\n   * Uncontrolled hypertension\n\n     * Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.\n   * Uncontrolled diabetes: Severe diabetes is defined as follows:\n\n     * Severe hyperglycemia with HbA1C ≥ 10.0%\n     * Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks.\n     * Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose \\\u003C54 mg\u002FdL) accompanied by seizures and loss of consciousness.\n   * Other viral infections \\[Ex. Human Immunodeficiency Virus(HIV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV)\\]. However, patients who are tested negative for HBsAg and positive for anti-HBcAb are not subject to this exclusion criterion.\n   * Tuberculosis\n   * Syphilis\n   * Moderate or severe liver damage \\[Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN)\\]\n   * Chronic kidney disease \\[eGFR \\\u003C 30mL\u002Fmin\u002F1.73m\\^2\\]\n   * Patients with other uncontrolled infections. However, the following cases are considered controlled infections and do not meet the exclusion criteria:\n\n     * Bacterial infection. Patients must be undergoing definitive antibiotic treatment for the infection and must have shown no signs of progression of the infection for 72 hours prior to enrollment in this clinical trial.\n     * Fungal infection. The patient must be receiving systemic antifungal therapy and must have shown no signs of infection progression for 1 week prior to enrollment in this clinical trial.\n3. Patients who have undergone allogeneic hematopoietic stem cell transplantation within 28 days prior to the scheduled first dose, or who have received donor lymphocyte infusion (DLI) within 28 days prior to enrollment in this clinical trial.\n4. Patients with active acute graft-versus-host disease (GvHD) of grade 2 or higher.\n5. Patients requiring urgent anticancer therapy due to rapid tumor progression.\n6. Patients with a history of substance abuse within 24 weeks prior to administration of the investigational drug, or patients suspected of taking drugs of concern based on medical history and physical examination.\n7. Patients requiring vasopressors.\n8. Patients who have previously shown hypersensitivity to T-cell therapy.\n9. Patients with a history of autoimmune disease.\n10. Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants.\n11. Patients who have received another virus-specific T cell product within 28 days prior to administration of the investigational drug.\n12. Patients with a life expectancy of less than 24 hours at the time of the screening visit.\n13. Patients aged under 19.\n14. Patients deemed ineligible for participation in this clinical trial by the investigator.",{"count":60,"type":20},27,[62,63],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after anticancer therapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:\n\n* What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting toxicity?\n* Does the number of CMV, BKV, or EBV virus viral load decrease within 7 or 14 days after the second infusion of LB-DTK-MV?\n* Do treatment emergent adverse events occur after the second infusion?\n\nParticipants will:\n\n* Receive a single intravenous infusion of LB-DTK-MV during the baseline visit (low dose: 1x10\\^7\u002Fm\\^2; high dose: 2x10\\^7\u002Fm\\^2).\n* Receive the second infusion of LB-DTK-MV intravenously at the same dose 14 days after the first infusion.\n* Attend weekly follow-up visits at the clinic for 6 months after the first dose.",[66,67,68],"BKV Infection","EBV Infection","CMV Infection",[28,70,71,72,73,74,75,76,30,77,78,79,80],"EBV","BKV","Multi-virus","CMV-associated diseases","EBV-associated diseases","BKV-associated diseases","Allogeneic Hematopoietic Stem Cell Transplantation","Infections","Virus Diseases","Antiviral-resistant infection","Anticancer therapy","2026-06-19",{"date":83,"type":43},"2026-06-26",{"date":85,"type":43},"2025-12-04",{"date":87,"type":20},"2027-06-04",{"name":49,"class":50},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100641393","phase-1-evaluation-of-the-safety-and-efficacy-of-lb-dtk-bkv-in-patients-with-bk-virus-associated-hemorrhagic-cystitis-following-allogeneic-hematopoietic-stem-cell-transplantation-100641393","NCT07638332","Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation.","A Single-Center, Open-Label, Phase 1\u002F2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation in Children, Adolescents, and Adults.","Inclusion Criteria:\n\n1. Patients who have undergone allogeneic hematopoietic stem cell transplantation, including pediatric and adolescent patients as well as adults who were 12 years of age or older at the time of transplantation. However, only adults aged 19 years or older are eligible for enrollment in Phase 1.\n2. Patients diagnosed with BK virus-associated hemorrhagic cystitis who meet all three of the following criteria.\n\n   * Clinical symptoms and signs of cystitis, such as lower abdominal pain and dysuria\n   * Hematuria of grade 2 or higher according to the Bedi criteria\n   * Detection of BKV \\>7log10 copies\u002FmL in urine\n3. Subjects confirmed by the investigator to be unresponsive to treatment despite at least 7 days of standard inpatient therapy.\n4. Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5 × 10³\u002FμL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.\n5. Patients for whom at least 21 days (D+21) have elapsed since allogeneic hematopoietic stem cell transplantation as of the screening date.\n6. Patients who are able to reduce their steroid dosage to 0.5 mg\u002Fkg\u002Fday of prednisolone (or an equivalent dose) or less.\n7. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.\n8. Female subjects or male subjects with female partners who agree to use the following contraceptive methods during the duration of this clinical trial and who meet the following criteria:\n\n   * Female participants or male participants with female partners who are postmenopausal (diagnosed with non-therapy-induced amenorrhea for 12 months or more or menopause)\n   * Female subjects or the female partners of male subjects who are surgically sterile (i.e., lacking ovaries and\u002For a uterus)\n   * Individuals who have agreed to strict abstinence during the clinical trial period \\[For female participants, intermittent abstinence (e.g., withdrawal during ovulation, the basal body temperature method, or withdrawal after ovulation) does not constitute agreement to abstinence\\]\n   * If the female subject or the female partner of a male subject is a woman of childbearing potential (WOCBP) who has not undergone sterilization, those who meet the following criteria:\n\n     * Hormonal contraceptives (implant, patch, oral)\n     * Intrauterine devices\n     * Dual barrier method (simultaneous use of the following two contraceptive methods: male condoms, female condoms, cervical caps, contraceptive diaphragms, contraceptive sponges)\n9. Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions.\n10. Individuals deemed suitable as trial subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).\n\nExclusion Criteria:\n\n1. Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.\n2. Patients with hemorrhagic cystitis caused by adenovirus (excluded via urine PCR)\n3. Patients with bacterial growth in urine culture (excluded via bacterial culture)\n4. Individuals who meet any of the following criteria at the time of screening:\n\n   * Uncontrolled hypertension\n\n     * Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.\n   * Uncontrolled diabetes: Severe diabetes is defined as follows.\n\n     * Severe hyperglycemia with HbA1C ≥ 10.0%\n     * Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks.\n     * Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose \\\u003C54 mg\u002FdL) accompanied by seizures and loss of consciousness.\n   * Human Immunodeficiency Virus (HIV) infection\n   * Hepatitis B Virus (HBV) infection. However, individuals who are HBsAg-negative and Anti-HBcAb-positive are not subject to this exclusion criterion.\n   * Hepatitis C Virus (HCV) infection\n   * Tuberculosis\n   * Syphilis\n   * Moderate or severe liver damage \\[Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN)\\]\n   * Patients with other uncontrolled infections. However, the following cases are considered controlled infections and do not meet the exclusion criteria.\n\n     * Bacterial infection Patients must be undergoing definitive antibiotic treatment for the infection and must have shown no signs of progression of the infection for 72 hours prior to enrollment in this clinical trial.\n     * Fungal infection The patient must be receiving systemic antifungal therapy and must have shown no signs of infection progression for 1 week prior to enrollment in this clinical trial.\n5. Patients who have undergone allogeneic hematopoietic stem cell transplantation within 28 days prior to the scheduled first dose, or who have received donor lymphocyte infusion (DLI) within 28 days prior to enrollment in this clinical trial.\n6. Active acute graft-versus-host disease (GvHD) of grade 3 or higher.\n7. Patients requiring urgent anticancer therapy due to rapid tumor progression.\n8. Patients with a history of substance abuse within 24 weeks prior to administration of the investigational drug, or patients suspected of taking drugs of concern based on medical history and physical examination.\n9. Patients requiring vasopressors.\n10. Patients who have previously shown hypersensitivity to T-cell therapy.\n11. Patients with a history of autoimmune disease.\n12. Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants.\n13. Patients who have received another investigational drug within 24 weeks prior to administration of the investigational drug.\n14. Patients with a life expectancy of less than 24 hours at the time of the screening visit.\n15. Patients deemed ineligible for participation in this clinical trial by the investigator.","12 Years",{"count":98,"type":20},42,[62,63],"The goal of this clinical trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem cell transplantation (allo-HSCT). It will also evaluate the safety of LB-DTK-BKV using treatment-emergent adverse events (TEAEs). The main questions it aims to answer are:\n\n* Does LB-DTK-BKV reduce the number of BKV virus viral load in allo-HSCT patients with hemorrhagic cystitis?\n* Do adverse events occur after the second dose? Researchers will compare LB-DTK-BKV to a placebo to see if LB-DTK-BKV works to treat hemorrhagic cystitis in allo-HSCT patients.\n\nParticipants will:\n\n* Receive a single intravenous infusion of LB-DTK-BKV at the baseline visit (low dose: 1x10\\^7\u002Fm\\^2; high dose: 2x10\\^7\u002Fm\\^2).\n* Receive the second dose of LB-DTK-BKV intravenously at the same dose 14 days after the first dose.\n* Visit the clinic every week for follow-up for 6 months after the first dose.",[102],"Hemorrhagic Cystitis",[104,102,30,76,105,78,77,106],"BK-Virus","Stem Cell Transplant","Cystitis","NOT_YET_RECRUITING","2026-06-15",{"date":110,"type":43},"2026-06-17",{"date":112,"type":20},"2026-09-01",{"date":114,"type":20},"2028-03-01",{"name":49,"class":50},9,""]