[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai BDgene Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,69,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100552542","phase-2-a-phase-a-study-of-the-safety-tolerability-and-efficacy-of-bd111-in-herpes-simplex-virus-type-i-stromal-keratitis-100552542",false,"NCT06474442","A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis","A Multicenter, Single-blind, Single-dose, Randomized, Phase Ⅱa Trial to Evaluate the Safety, Tolerability and Efficacy of Intrastromal BD111 Gene Editing Therapy in Adults With HSV-1 Stromal Keratitis","Inclusion Criteria: Participants must meet all of the following inclusion criteria to be enrolled in this study.\n\n1. Aged 18 to 70 years old;\n2. Clinically diagnosed with herpes simplex virus stromal keratitis;\n3. Tear swab HSV-1 nucleic acid test (qPCR method) positive;\n4. No use of systemic antiviral drugs or corticosteroids within 48 hours before enrollment;\n5. No systemic immune eye diseases;\n6. Good eyelid structure and blinking function;\n7. Eye structure and function assessment showing potential for visual recovery;\n8. No retinal detachment, with generally normal visual function;\n9. No history of corneal trauma;\n10. Visual acuity in the fellow eye is better than 20\u002F200;\n11. Fertile males or females must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicides) during the trial and continue contraception for 12 months after administration;\n12. Participants voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up visits.\n\nExclusion Criteria: Patients with any of the following conditions cannot be enrolled in this study\n\n1. Active ocular infection caused by other pathogens in the target eye or the fellow eye within 30 days before enrollment, including but not limited to blepharitis, infectious conjunctivitis, keratitis, scleritis, and endophthalmitis;\n2. Patients with bilateral viral keratitis\n3. Previous corneal transplant surgery in the study eye;\n4. A history of adverse reactions or allergies to corticosteroids and sodium fluorescein, allergies to therapeutic or diagnostic protein products, allergies to ≥ two drugs or non-drug factors, or having an ongoing allergic disease;\n5. Absence of tear film and blinking function;\n6. Severe dry eye disease;\n7. Malignant ocular surface tumor;\n8. Glaucoma;\n9. Patients with systemic autoimmune diseases;\n10. Signs of systemic infection before enrollment, including fever and receiving antibiotic treatment (abnormal elevating values in white blood cells, lymphocytes, and neutrophils in routine blood tests);\n11. Abnormal major organ function or other uncontrolled clinical problems, mainly including but not limited to the following:\n\n    * Severe kidney disease history, serum creatinine ≥ 133μmol\u002FL;\n    * Liver dysfunction, transaminase level ≥ 80 IU\u002FL;\n    * Uncontrolled hypertension, systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg;\n    * Uncontrolled diabetes, fasting blood glucose greater than or equal to 8.0 μmol\u002FL;\n    * Cardiovascular disease history, with arrhythmia, myocardial ischemia, and myocardial infarction (diagnosed by electrocardiogram examination);\n    * Platelet level ≤ 100×10\\^9\u002FμL or ≥ 450×10\\^9\u002FμL due to any cause, hemoglobin level lower than 10.0g\u002FdL (male) or 9.0g\u002FdL (female).\n12. HIV infection;\n13. Pregnant and lactating women (pregnancy in this trial is defined as a positive urine pregnancy test);\n14. Participation in other drug or medical device clinical trials;\n15. Alcohol or drug abuse;\n16. Lack of compliance with the trial or the ability to sign an informed consent form;\n17. Other situations deemed unsuitable for participation in the trial by the investigator.","ALL","18 Years","70 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study aims to compare the clinical efficacy and safety of BD111 injection in combination with standard therapy vs. standard therapy in herpes simplex virus type I stromal keratitis (HSK), providing preliminary confirmation of the clinical effectiveness of BD111 in combination with standard therapy.",[27],"Herpes Simplex Virus Type I Stromal Keratitis",[29,30],"Herpes Simplex Virus Type I","Stromal Keratitis","RECRUITING","2025-05-14",{"date":34,"type":35},"2025-05-18","ACTUAL",{"date":37,"type":35},"2025-04-28",{"date":39,"type":21},"2027-03",{"name":41,"class":42},"Shanghai BDgene Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100551858","phase-1-a-phase-1-study-of-gene-modified-autologous-hematopoietic-stem-cell-bd211-treating--thalassemia-major-100551858","NCT06465550","A Phase 1 Study of Gene-modified Autologous Hematopoietic Stem Cell (BD211) Treating β-thalassemia Major","A Phase 1 Clinical Trail of the Safety and Efficacy of Gene-modified Autologous Hematopoietic Stem Cell (BD211) Intravenous Infusion for the Treatment of Transfusion-dependent β-thalassaemia Patients","Inclusion Criteria:\n\n1. Participants aged 3 years (inclusive) to 18 years (exclusive), with no gender restrictions.\n2. Parents\u002Flegal guardians have fully understood and voluntarily signed a written informed consent form; and it is recommended that children aged 8 and above be involved in the decision to participate in this clinical trial and obtain a written consent form.\n3. Transfusion-dependent β-thalassemia patients. \"Transfusion-dependent\" is defined as: requiring at least 100 mL\u002Fkg of packed red blood cells annually; the genotype can be β0\u002Fβ0, β0\u002Fβ+, or β+\u002Fβ+, diagnosed through hemoglobin studies.\n4. Eligible for allogeneic hematopoietic stem cell transplantation, but without a donor or those refusing to undergo allogeneic hematopoietic stem cell transplantation.\n5. Have undergone symptomatic treatment for at least the past 2 years and have retained medical records including transfusion history.\n6. Stable condition and maintained an appropriate iron chelation regimen.\n7. Good status of organ function.\n8. Good compliance from the individual and parents\u002Flegal guardians, willing to adhere to visit schedules, trial plans, laboratory tests, and other trial procedures as stipulated in this protocol.\n9. Willing to participate in long-term follow-up research.\n\nExclusion Criteria:\n\n1. Has a fully HLA-matched hematopoietic stem cell donor and is willing to receive a fully HLA-matched hematopoietic stem cell transplant. Enrollment is otherwise only advised after review by the safety review committee.\n2. Positive for antibodies against Human Immunodeficiency Virus 1\u002F2 (HIV-1\u002FHIV-2), Treponema pallidum (TP) specific antibodies, Human T-lymphotropic Virus 1 or 2 (HTLV-1\u002FHTLV-2) antibodies, and Vesicular Stomatitis Virus G (VSV-G).\n3. Positive for Hepatitis B Virus (HBV) HbsAg or HBV-DNA; Hepatitis C Virus (HCV) HCAb positive; positive nucleic acid test for Epstein-Barr Virus (EBV) or Cytomegalovirus (CMV).\n4. Severe active bacterial, viral, fungal, malarial, or parasitic infections.\n5. Has had, or currently has, a malignant, myeloproliferative, or immunodeficiency disorder.\n6. Direct relatives with known or suspected hereditary cancer syndromes (including but not limited to breast cancer, colorectal cancer, ovarian cancer, prostate cancer, and pancreatic cancer).\n7. Autoimmune diseases that could result in transfusion difficulties.\n8. Major organ diseases or abnormal lab tests, including:\n\n   1. Liver cirrhosis, fibrosis, or active hepatitis, and\u002For abnormal liver function tests (Serum total bilirubin (TBIL) ≥ 1.5x Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≥ 2.5x ULN; Alkaline phosphatase ≥ 2.5x ULN).\n   2. Heart disease, or Left Ventricular Ejection Fraction (LVEF) \\\u003C 60%.\n   3. Kidney diseases, or serum creatinine ≥ 1.5ULN, creatinine clearance rate \\\u003C 30% of the normal level (measured or calculated by the Cockcroft-Gault equation).\n   4. Endocrine disorders, such as insulin-dependent diabetes, hyperthyroidism, or hypothyroidism.\n   5. Severe iron overload, serum ferritin ≥ 5000 ng\u002FmL.\n   6. Cardiac T2\\* \\\u003C 20 ms, and\u002For liver iron content (LIC) ≥ 15mg\u002Fg liver weight by MRI.\n   7. Significant pulmonary hypertension diagnosed clinically according to guidelines, requiring clinical medical intervention.\n9. Uncorrected bleeding disorders.\n10. Severe psychiatric disorders.\n11. Peripheral blood white cell (WBC) count \\\u003C 3x10\\^9\u002FL or platelets count \\\u003C 120x10\\^9\u002FL.\n12. Received hydroxyurea treatment within the last 3 months before stem cell collection.\n13. Used erythropoiesis-stimulating agents within the 3 months prior to HSC collection.\n14. History of allogeneic transplantation.\n15. Previously received any type of gene and\u002For cell therapy.\n16. Participating in another clinical trial and is within a 30-day screening period.\n17. Has contraindications to anesthesia.\n18. Has contraindications to hematopoietic stem cell collection.\n19. Allergic to the investigational drug or its excipients.\n20. Any other conditions determined by the investigator as unsuitable for participation in this clinical trial.","3 Years","35 Years",{"count":54,"type":21},9,[56],"PHASE1","This study will be intented to evaluate the safety, tolerability, and engraftment efficacy after myeloablative preconditioning and transplantation of autologous CD34+ hematopoietic stem cells transduced with a lentiviral vector encoding the human βA-T87Q-globin gene in patients with transfusion-dependent (TDT) β-thalassemia.",[59],"β-thalassemia","2024-06-19",{"date":62,"type":35},"2024-06-24",{"date":64,"type":35},"2024-01-05",{"date":66,"type":21},"2026-12",{"name":41,"class":42},3,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":52,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":57,"conditions":81,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":43},"100498893","safety-and-efficacy-of-gene-modified-autologous-hematopoietic-stem-cells-to-treat-transfusion-dependent--thalassemia-100498893","NCT05776173","Safety and Efficacy of Gene Modified Autologous Hematopoietic Stem Cells to Treat Transfusion-dependent β-thalassemia","Safety and Efficacy of Lentiviral Vector Transduction of β-globin Genetically Modified Autologous CD34+ Hematopoietic Stem Cells in Patients With Transfusion-dependent β-thalassemia","Inclusion Criteria:\n\n1. Ages 6 to 35 years old, including:\n\n   Subjects should be able to provide an ICF. Diagnosed as Transfusion Dependent β-thalassemia with any genotype (β0, β+, βE\u002Fβ0, βS\u002FS, βS\u002Fβ0, βS\u002Fβ+), confirmed the Hb analysis. No alfa chain genetic abnormalities. Subjects must stabilize and maintain an appropriate iron chelation regimen. Transfusion-dependent types are defined as requiring at least 100 mL\u002Fkg\u002F year of red blood cells (pRBCs).\n2. The tumor genes chip detection results about acute leukemia and myeloid tumor gene mutations (panel) showed no abnormality.\n3. There were candidates for HLA gene semi-compatible hematopoietic stem cell transplantation.\n4. No eligiblity for allogeneic hematopoietic stem cell transplantation.\n5. The treatment of erythrocyte maturation agent luspatercept cannot be financially supported.\n6. The investigator confirmed that subject was willing to follow the research procedures.\n7. Having complete medical records including a history of blood transfusions testified subject received treatment and followed up for at least two years prior to screening.\n\nExclusion Criteria:\n\n1. Availability of voluntary, fully HLA-matched hematopoietic cell donors, unless recommended for inclusion by the Monitoring Committee.\n2. HIV-1 and HIV-2 were positive, and \u002F or HTLV-1, HTLV-2 and VSV-G antibodies were positive.\n3. An active bacterial, viral, fungal or parasitic infection.\n4. Contraindicated for the extraction of bone marrow under anesthesia.\n5. Any malignancy, myeloproliferative, or immunodeficient disease and relevant medical history.\n6. Peripheral blood white blood cell (WBC) count \\\u003C 3×10\\^9\u002FL or platelet count \\\u003C 120×10\\^9\u002FL.\n7. A history of allo-transplantation.\n8. Erythropoietin was used within 3 months prior to HSC cell collection.\n9. Immediate family members with known or suspected familial cancer syndromes (including but not limited to breast, colorectal, ovarian, prostate, and pancreatic cancers).\n10. Subjects with a diagnosis of major mental illness may had a serious disability to participate in the study.\n11. Active recurrent malaria.\n12. Pregnant or postpartum nursing or unable to use contraception.\n13. History of major organ injury including:\n\n    Liver disease, transaminase \\> 3 times the upper limit of normal. (If the liver biopsy does not reveal evidence of widespread bridging fibrosis, cirrhosis, or acute hepatitis, this indicator will not be used as a criterion for the exclusion); Widely bridging fibrosis, histopathological evidence of acute hepatitis or cirrhosis showed in liver biopsy Heart disease, left ventricular ejection fraction \\\u003C 25%; Kidney disease, creatinine clearance \\\u003C 30% normal level; Of severe iron overload, confirmed by the study doctor; An heart MRI detection of T2 \\* \\\u003C 10 ms; Significant pulmonary hypertension needing clinical medical intervention.\n14. Any other conditions being ineligible for HSC transplantation determined by the investigator.\n15. The subject involved with another clinical study in a 30-day screening period.\n16. Subjects who expected to become parents during the 27-month study period.\n17. Prior treatment with any type of gene and\u002For cell therapy.\n18. As assessed by the investigator, the subjects or their parents are unable to comply well with the study procedures per protocol.\n19. Hydroxyurea treatment within 3 months prior to hematopoietic stem cell collection.","6 Years",{"count":78,"type":21},10,[80],"NA",[82],"β-thalassemia Major","2024-06-13",{"date":85,"type":35},"2024-06-14",{"date":87,"type":35},"2023-08-10",{"date":89,"type":21},"2026-10",{"name":41,"class":42},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":74,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":17,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":57,"conditions":99,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":43},"100498705","safety-and-efficacy-of-gene-modified-autologous-hematopoietic-stem-cells-to-treat-transfusion-dependent-beta-thalassemia-100498705","NCT05773729","Safety and Efficacy of Gene Modified Autologous Hematopoietic Stem Cells to Treat Transfusion-dependent Beta-thalassemia","Inclusion Criteria:\n\n1. Ages 3 to 18 years old, including:\n\n   The parents or legal guardians must be able to understand and provide ICFs. If available, it is strongly recommended that children aged ≥8 years in treatment decisions and obtain written ICFs and be clearly documented; Diagnosed as Transfusion Dependent β-thalassemia with any genotype (β0, β+, βE\u002Fβ0, βS\u002FS, βS\u002Fβ0, βS\u002Fβ+), confirmed the Hb analysis. No alfa chain genetic abnormalities. Subjects must stabilize and maintain an appropriate iron chelation regimen. Transfusion-dependent types are defined as requiring at least 100 mL\u002Fkg\u002F year of red blood cells (pRBCs).\n2. No eligiblity for allogeneic hematopoietic stem cell transplantation.\n3. The treatment of erythrocyte maturation agent luspatercept cannot be financially supported.\n4. The subjects' parents\u002Flegal guardians must be willing and able to follow the study procedures in the study protocol.\n5. Good organs' functions.\n6. Having complete medical records including a history of blood transfusions testified subject received treatment and followed up for at least two years prior to screening .\n\nExclusion Criteria:\n\n1. Availability of voluntary, fully HLA-matched hematopoietic cell donors, unless recommended for inclusion by the Monitoring Committee.\n2. HIV-1 and HIV-2 were positive, and \u002F or HTLV-1, HTLV-2 and VSV-G antibodies were positive.\n3. An active bacterial, viral, fungal or parasitic infection.\n4. Contraindicated for the extraction of bone marrow under anesthesia.\n5. Any malignancy, myeloproliferative, or immunodeficient disease and relevant medical history.\n6. Peripheral blood white blood cell (WBC) count \\\u003C 3×10\\^9\u002FL or platelet count \\\u003C 120×10\\^9\u002FL.\n7. A history of allo-transplantation.\n8. Erythropoietin was used within 3 months prior to HSC cell collection.\n9. Immediate family members with known or suspected familial cancer syndromes (including but not limited to breast, colorectal, ovarian, prostate, and pancreatic cancers).\n10. Subjects with a diagnosis of major mental illness may had a serious disability to participate in the study.\n11. Active recurrent malaria.\n12. Had autoimmune diseases that may make blood transfusions difficult.\n13. History of major organ injury including:\n\n    Liver disease, transaminase \\> 3 times the upper limit of normal. (If the liver biopsy does not reveal evidence of widespread bridging fibrosis, cirrhosis, or acute hepatitis, this indicator will not be used as a criterion for the exclusion); Widely bridging fibrosis, histopathological evidence of acute hepatitis or cirrhosis showed in liver biopsy Heart disease, left ventricular ejection fraction \\\u003C 25%; Kidney disease, creatinine clearance \\\u003C 30% normal level; Of severe iron overload, confirmed by the study doctor; An heart MRI detection of T2 \\* \\\u003C 10 ms; Significant pulmonary hypertension needing clinical medical intervention.\n14. There are bleeding diseases that have not been cured.\n15. The subject involved with another clinical study in a 30-day screening period.\n16. Allergic to the research drug and its excipients.\n17. Prior treatment with any type of gene and\u002For cell therapy.\n18. As assessed by the investigator, the subjects or their parents are unable to comply well with the study procedures per protocol.\n19. Hydroxyurea treatment within 3 months prior to hematopoietic stem cell collection.\n20. Had diseases that interfere with hematopoietic stem cells collections.\n21. Any other conditions being ineligible for HSC transplantation determined by the investigator.",{"count":78,"type":21},[80],[59],{"date":85,"type":35},{"date":102,"type":35},"2023-09-15",{"date":89,"type":21},{"name":41,"class":42},""]