[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580726":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":181,"collaborators":20,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":20,"eligibilityCriteria":189,"healthyVolunteers":185,"sex":190,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":20,"studyType":196,"phases":197,"briefSummary":200,"conditions":201,"keywords":20,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"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,[22,40,49,60,71,82,93,104,115,126,137,148,159,170],{"facility":23,"status":24,"city":25,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":29,"coordinates":30},"Point",[31,32],116.39723,39.9075,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":20,"email":39},"XiaoFeng Zeng M.D.","CONTACT","13501069845","xiaofeng.zeng@cstar.org.cn",{"facility":41,"status":42,"city":25,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":43,"geoPoint":45,"contacts":46},"Xuanwu Hospital, Capital Medical University","NOT_YET_RECRUITING",{"type":29,"coordinates":44},[31,32],{"lat":32,"lon":31},[47],{"name":48,"role":37,"phone":20,"phoneExt":20,"email":20},"Yi Zhao",{"facility":50,"status":42,"city":51,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Jilin Provincial People's Hospital","Changchun",{"type":29,"coordinates":53},[54,55],125.32278,43.88,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":20,"phoneExt":20,"email":20},"Guoping Jiang",{"facility":61,"status":42,"city":62,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Guangdong Provincial People's Hospital","Guangzhou",{"type":29,"coordinates":64},[65,66],113.25,23.11667,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":20,"phoneExt":20,"email":20},"Yang Li",{"facility":72,"status":42,"city":73,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Zhejiang Provincial People's 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Xu",{"facility":105,"status":42,"city":106,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Linfen Central Hospital","Linfen",{"type":29,"coordinates":108},[109,110],111.51889,36.08889,{"lat":110,"lon":109},[113],{"name":114,"role":37,"phone":20,"phoneExt":20,"email":20},"Shuhua Qiang",{"facility":116,"status":42,"city":117,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Mianyang Central Hospital","Mianyang",{"type":29,"coordinates":119},[120,121],104.68168,31.46784,{"lat":121,"lon":120},[124],{"name":125,"role":37,"phone":20,"phoneExt":20,"email":20},"Jing Yang",{"facility":127,"status":42,"city":128,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"The First Affiliated Hospital of Nanchang 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Zhang",{"facility":160,"status":42,"city":161,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"The First Affiliated Hospital of Xiamen University","Xiamen",{"type":29,"coordinates":163},[164,165],118.08187,24.47979,{"lat":165,"lon":164},[168],{"name":169,"role":37,"phone":20,"phoneExt":20,"email":20},"Guixiu Shi",{"facility":171,"status":42,"city":172,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Xinxiang Central Hospital","Xinxiang",{"type":29,"coordinates":174},[175,176],113.80151,35.19033,{"lat":176,"lon":175},[179],{"name":180,"role":37,"phone":20,"phoneExt":20,"email":20},"Wenqiang Fan",{"type":182,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100580726","phase-1-a-study-of-sctb35-in-patients-with-systemic-lupus-erythematosus-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":194,"type":195},168,"ESTIMATED","INTERVENTIONAL",[198,199],"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).",[202],"System Lupus Erythematosus","2025-02-18",{"date":205,"type":206},"2025-02-21","ACTUAL",{"date":208,"type":195},"2025-02",{"date":210,"type":195},"2028-10",{"name":5,"class":6},14]