[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Xinzhi BioMed Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100524661","phase-2-evaluation-of-the-safety-and-efficacy-of-hemophilia-a-gene-therapy-drugs-100524661",false,"NCT06111638","Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs","A Phase 1\u002F2\u002F3 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of an Adeno-associated Viral Vector Containing an Expression Cassette of the Human Factor VIII Transgene (BBM-H803) Injection in Participants With Hemophilia A","Inclusion Criteria of Phase 1\u002F2\u002F3:\n\n1. Subjects voluntarily sign informed consent form;\n2. Males ≥ 18 years;\n3. Subjects are clinically diagnosed with severe hemophilia A;\n4. Have \\> = 150 documented exposure days to a Factor VIII protein product\n5. No prior history of hypersensitivity or anaphylaxis associated with any FVIII immunoglobulin;\n6. Use a reliable contraception method during the study;\n7. Capsid antibody negative;\n8. Subjects have good compliance.\n\nExclusion Criteria of Phase 1\u002F2\u002F3:\n\n1. Being positive for hepatitis B surface antigen (HBsAg) or hepatitis B virus-DNA (HBV-DNA). Being positive for hepatitis C virus antibody (HCV-Ab) or hepatitis C virus RNA (HCV-RNA).\n\n   Subjects with medical history of hepatitis B or C can be regarded as negative only when 2 required samplings are conducted at least 3 months apart and both test results of indicators aforementioned are negative, HIV positive patients or Syphilis seropositive patients;\n2. Currently on antiviral therapy for hepatitis B or C;\n3. Suffer from coagulation disorders other than hemophilia A;\n4. In addition to glucocorticoids, any other immunosuppressants are being used before selection;\n5. Have vaccination history within 2 months before administration, or vaccination schedule during immunomodulatory therapy;\n6. Have potential liver diseases, such as previous diagnosis of portal hypertension, splenomegaly, hepatic encephalopathy or liver fibrosis (fibrosis stage ≥ 3); nodules or cysts were found by B ultrasound, or elevated alpha-fetoprotein was detected by laboratory tests. Subjects who are not eligible for the study if the abnormalities are clinically significant regarding to the medical judgement of the investigator;\n7. Scheduling of elective major surgery known or planned during the insertion period or the 52-week study period following BBM-H803 infusion;\n8. Have participated in a previous gene therapy research trial before screening or have used other test drugs within 4 weeks before screening, or within 5 half-life of the test drug, whichever is longer; Have received emesezumab within 6 months before screening; Or drugs evaluated by the researcher to affect the study;\n9. Any herbal preparations (herbal supplements or traditional Chinese medicines of plant, mineral or animal origin) used during the 4 weeks prior to or during the study that may affect liver function, except topical use; Or any Chinese herbal medicine that the researcher evaluates to affect the study;\n10. Have alcohol or drug addiction, or cannot stop drinking as advised by the researcher throughout the study;\n11. Have acute\u002Fchronic infections or other chronic diseases that may pose a risk for the study, or have a major illness, who have a current or previous history of malignant tumors, or who have other unstable medical conditions, including poor mental state and risk of suicide, that the investigator deems unsuitable for participation in the study;\n12. Any other conditions that the investigator deems unsuitable for participation in the study.","MALE","18 Years",{"count":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This is a multi-center, Phase 1\u002F2\u002F3, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H803 injection in severe Hemophilia A subjects.\n\nBBM-H803 is an adeno-associated viral (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor VIII transgene and raises circulating levels of endogenous FVIII.",[27],"Hemophilia A",[27,29,30],"gene therapy","Adeno-Associated Virus","RECRUITING","2026-03-13",{"date":34,"type":35},"2026-03-17","ACTUAL",{"date":37,"type":35},"2024-01-03",{"date":39,"type":20},"2031-05-30",{"name":41,"class":42},"Shanghai Xinzhi BioMed Co., Ltd.","INDUSTRY",10,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100607997","phase-1-a-clinical-study-to-evaluate-the-safety-and-tolerability-of-bbm-p002-in-the-treatment-of-parkinsons-disease-100607997","NCT07195825","A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease","A Single-arm, Open-label, Single-dose Clinical Study to Evaluate the Safety and Tolerability of BBM-P002 for Stereotactic Bilateral Putamen Injection in the Treatment of Idiopathic Parkinson's Disease","Inclusion Criteria:\n\n1. Participants with a diagnosis of Parkinson's disease for ≥ 5 years.\n2. The Hoehn-Yahr staging meets the requirements during the OFF periods.\n3. The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive\n4. During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly\n5. The participants agreed to postpone the neurosurgical procedures related to the indication treatment during the main study phase\n6. The participants agreed not to participate in any other therapeutic intervention studies during the trial period\n7. The participants agreed not to receive the vaccine during the main study phase\n8. From the screening period until at least 52 weeks after dosing, use a reliable contraceptive method\n9. The participants had good compliance and were able to undergo regular follow-ups. During the follow-up period, they were able to accurately complete the diary cards. Family members, guardians or caregivers could assist the subjects in filling out the diary cards\n10. Voluntarilyvoluntarily participated in the study and signed the informed consent form\n\nExclusion Criteria:\n\n1. Atypical or secondary Parkinsonism\n2. Have contraindications for surgery or have previously undergone brain surgery\n3. The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease\n4. Those with severe cognitive impairments\n5. Those with severe depression or severe anxiety\n6. Abnormal liver function\n7. Abnormal coagulation function\n8. Abnormalities in infectious disease screening\n9. Currently undergoing antiviral treatment for hepatitis\n10. Suffering from unstable or severe diseases in the cardiovascular, respiratory, digestive, nervous, hematological, immune and other systems\n11. Suffering from malignant tumors or having a history of tumors\n12. Previous history of severe allergies\n13. Exclude those who have participated in other clinical trials within the past three months\n14. Had received gene therapy during the screening period\n15. Select those who have received stem cell treatment within the past 12 months\n16. Exclude those who have used other investigational drugs within the past 4 weeks\n17. During the screening period, if the individual had received live vaccines within the previous 2 months, or had a history of vaccination within the last 30 days, they would be excluded.\n18. Having a history of alcohol dependence or drug addiction\n19. Pregnant or lactating female participants\n20. The situations that were determined by the investigator to be unsuitable for inclusion in the study","ALL","40 Years","70 Years",{"count":55,"type":20},18,[57],"PHASE1","The purpose of the study is to evaluate the safety and tolerability of BBM-P002 for stereotactic injection to treat participants with idiopathic Parkinson's Disease (PD) during the dose-limiting toxicity (DLT) observation period.",[60],"PD",[60,29,30],"2026-01-27",{"date":64,"type":35},"2026-01-28",{"date":66,"type":35},"2025-12-27",{"date":68,"type":20},"2031-12-30",{"name":41,"class":42},1,""]