[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580726":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":180,"collaborators":20,"id":182,"slug":20,"hasResults":183,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":20,"eligibilityCriteria":187,"healthyVolunteers":183,"sex":188,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":20,"studyType":194,"phases":195,"briefSummary":198,"conditions":199,"keywords":20,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: SCTB35","EXPERIMENTAL","SCTB35 will be administered every 21 days per treatment cycle.",[13],"Biological: SCTB35 injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","SCTB35 injection","SCTB35 will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTB35 will be applied for the dose-expansion cohorts.",[9],null,[22,39,48,59,70,81,92,103,114,125,136,147,158,169],{"facility":23,"status":24,"city":25,"state":20,"zip":20,"country":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","China",{"type":28,"coordinates":29},"Point",[30,31],116.39723,39.9075,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":20,"email":38},"XiaoFeng Zeng M.D.","CONTACT","13501069845","xiaofeng.zeng@cstar.org.cn",{"facility":40,"status":41,"city":25,"state":20,"zip":20,"country":26,"cosmosGeoPoint":42,"geoPoint":44,"contacts":45},"Xuanwu Hospital, Capital Medical University","NOT_YET_RECRUITING",{"type":28,"coordinates":43},[30,31],{"lat":31,"lon":30},[46],{"name":47,"role":36,"phone":20,"phoneExt":20,"email":20},"Yi Zhao",{"facility":49,"status":41,"city":50,"state":20,"zip":20,"country":26,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Jilin Provincial People's Hospital","Changchun",{"type":28,"coordinates":52},[53,54],125.32278,43.88,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":20,"phoneExt":20,"email":20},"Guoping Jiang",{"facility":60,"status":41,"city":61,"state":20,"zip":20,"country":26,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Guangdong Provincial People's Hospital","Guangzhou",{"type":28,"coordinates":63},[64,65],113.25,23.11667,{"lat":65,"lon":64},[68],{"name":69,"role":36,"phone":20,"phoneExt":20,"email":20},"Yang Li",{"facility":71,"status":41,"city":72,"state":20,"zip":20,"country":26,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Zhejiang Provincial People's Hospital","Hangzhou",{"type":28,"coordinates":74},[75,76],120.16142,30.29365,{"lat":76,"lon":75},[79],{"name":80,"role":36,"phone":20,"phoneExt":20,"email":20},"Yashong Li",{"facility":82,"status":41,"city":83,"state":20,"zip":20,"country":26,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"The First People's Hospital of Jiujiang City","Jiujiang",{"type":28,"coordinates":85},[86,87],116.00206,29.70475,{"lat":87,"lon":86},[90],{"name":91,"role":36,"phone":20,"phoneExt":20,"email":20},"Ju Liu",{"facility":93,"status":41,"city":94,"state":20,"zip":20,"country":26,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"The First Affiliated Hospital of Kunming Medical University","Kunming",{"type":28,"coordinates":96},[97,98],102.71833,25.03889,{"lat":98,"lon":97},[101],{"name":102,"role":36,"phone":20,"phoneExt":20,"email":20},"Jian Xu",{"facility":104,"status":41,"city":105,"state":20,"zip":20,"country":26,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Linfen Central Hospital","Linfen",{"type":28,"coordinates":107},[108,109],111.51889,36.08889,{"lat":109,"lon":108},[112],{"name":113,"role":36,"phone":20,"phoneExt":20,"email":20},"Shuhua 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Hu",{"facility":148,"status":41,"city":149,"state":20,"zip":20,"country":26,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Shanxi Bethune Hospital","Taiyuan",{"type":28,"coordinates":151},[152,153],112.56028,37.86944,{"lat":153,"lon":152},[156],{"name":157,"role":36,"phone":20,"phoneExt":20,"email":20},"Liyun Zhang",{"facility":159,"status":41,"city":160,"state":20,"zip":20,"country":26,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"The First Affiliated Hospital of Xiamen University","Xiamen",{"type":28,"coordinates":162},[163,164],118.08187,24.47979,{"lat":164,"lon":163},[167],{"name":168,"role":36,"phone":20,"phoneExt":20,"email":20},"Guixiu Shi",{"facility":170,"status":41,"city":171,"state":20,"zip":20,"country":26,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Xinxiang Central Hospital","Xinxiang",{"type":28,"coordinates":173},[174,175],113.80151,35.19033,{"lat":175,"lon":174},[178],{"name":179,"role":36,"phone":20,"phoneExt":20,"email":20},"Wenqiang Fan",{"type":181,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100580726",false,"NCT06841042","A Study of SCTB35 in Patients with Systemic Lupus Erythematosus","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTB35 in Patients with Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Age 18-75 years；\n2. Diagnosed with SLE for ≥12 weeks prior to screening (2019-ACR\u002FEULAR criteria);\n3. SLEDAI-2K ≥ 8 at screening, or ≥6 if there is hypocomplementemia or elevated anti-dsDNA antibody levels;\n4. Positive for ANA (1:80) or positive for anti-dsDNA and\u002For anti-Sm antibodies within the last 12 months or at screening;\n5. Currently receiving ≥1 stable dose of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs\n\n   1. Stable corticosteroid dose for ≥4 weeks prior to baseline;\n   2. Stable dose of antimalarial drugs for ≥4 weeks prior to baseline;\n   3. Stable dose of immunosuppressive agents for ≥4 weeks prior to baseline;\n6. All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 6 months after the last dose of the study drug;\n7. Understanding of the study procedures and voluntary signing of the informed consent form.\n\nExclusion Criteria:\n\n1. Severe active or unstable lupus-related neuropsychiatric disorders;\n2. Other autoimmune diseases that may interfere with efficacy evaluation;\n3. Catastrophic antiphospholipid syndrome;\n4. Received treatments that may affect the drug's effect:\n5. Received live vaccines or attenuated vaccines within 28 days prior to baseline or screening;\n6. Clinically significant bleeding risk;\n7. Abnormal laboratory results:\n\n   1. AST or ALT \\>2.5 x ULN;\n   2. Total bilirubin \\>1.5 x ULN;\n   3. ANC \\\u003C1.5x10⁹\u002FL;\n   4. Platelets \\\u003C75x10⁹\u002FL;\n   5. Hemoglobin \\\u003C100g\u002FL;\n8. eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²;\n9. Positive serum HCG;\n10. Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);\n11. Participants with recurrent, chronic, or other active infections as assessed by the investigator;\n12. Severe or uncontrolled disease, which would prevent participation in the study;\n13. Positive viral serology tests, including HIV, HCV, and HBV;\n14. Tuberculosis screening: Known active tuberculosis or latent tuberculosis infection (LTBI);\n15. Any type of active infection except nail bed fungal infections;\n16. Severe infections;\n17. History of progressive multifocal leukoencephalopathy (PML);\n18. Diagnosed with type 1 or type 2 diabetes with poor control;\n19. Uncontrolled hypertension (systolic \\>140 mmHg or diastolic \\>90 mmHg);\n20. History of malignancy within 5 years prior to baseline;\n21. Alcohol abuse or drug misuse within 12 months prior to screening;\n22. Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTB35 injection;\n23. Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;\n24. Participants with mental disorders or poor compliance;\n25. Severe lupus nephritis;\n26. History of solid organ or hematopoietic stem cell\u002Fbone marrow transplant, or expected to undergo transplant surgery during the study;\n27. Pregnant or breastfeeding;\n28. Any other condition that the investigator deems unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":192,"type":193},168,"ESTIMATED","INTERVENTIONAL",[196,197],"PHASE1","PHASE2","This study is a multicenter Phase Ib\u002FII clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).",[200],"System Lupus Erythematosus","2025-02-18",{"date":203,"type":204},"2025-02-21","ACTUAL",{"date":206,"type":193},"2025-02",{"date":208,"type":193},"2028-10",{"name":5,"class":6},14]