[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634320":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":23,"slug":20,"hasResults":24,"nctId":25,"briefTitle":26,"officialTitle":27,"acronym":20,"eligibilityCriteria":28,"healthyVolunteers":24,"sex":29,"minAge":30,"maxAge":31,"enrollmentInfo":32,"targetDuration":20,"studyType":35,"phases":36,"briefSummary":39,"conditions":40,"keywords":42,"overallStatus":44,"whyStopped":20,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":20},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental: SCTC21C","EXPERIMENTAL","SCTC21C will be administered to participants for about 24 weeks",[13],"Biological: SCTC21C",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","SCTC21C","SCTC21C will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTC21C will be applied for the dose-expansion cohorts",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100634320",false,"NCT07538154","A Clinica Study of SCTC21C in Participants With Systemic Lupus Erythematosus","A Phase Ib\u002FII Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTC21C in Participants With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Aged 18-75 years;\n2. Diagnosed with SLE for ≥12 weeks prior to screening, met the 2019 ACR\u002FEULAR diagnostic criteria for SLE screening period;\n3. SELENA-SLEDAI ≥8 at screening;\n4. Positive immunological markers within 12 months prior to baseline;\n5. Currently receiving ≥1 stable doses of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs;\n6. All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 5 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. Combined with active infections, malignant tumors, or other autoimmune diseases;\n3. Catastrophic antiphospholipid syndrome;\n4. severe lupus nephritis;\n5. Study participants who received a live or attenuated vaccine within 28 days prior to baseline or during the screening period;\n6. Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);\n7. Patients at high risk of severe clinical bleeding, or those requiring plasma transfusion, intravenous immunoglobulin, or acute blood products;;\n8. Patients who experienced any of the following cardiovascular or cerebrovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association (NYHA) Class II or higher heart failure, stroke, etc.;\n9. In accordance with the protocol requirements, participants with abnormal laboratory test results;\n10. Participants with positive results of viral serology, including Treponema pallidum, HIV, HCV, and HBV;\n11. participants with a history of tuberculosis or latent tuberculosis infection;\n12. Diagnosed with type 1 or type 2 diabetes with poor control;\n13. Uncontrolled hypertension;\n14. Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTC21C injection;\n15. Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;\n16. History of solid organ or hematopoietic stem cell\u002Fbone marrow transplant, or expected to undergo transplant surgery during the study;\n17. Pregnant or breastfeeding;\n18. Any other condition that the investigator deems unsuitable for participation in the study","ALL","18 Years","75 Years",{"count":33,"type":34},159,"ESTIMATED","INTERVENTIONAL",[37,38],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus",[41],"Systemic Lupus Erythematosus (SLE)",[43],"SLE","NOT_YET_RECRUITING","2026-04-12",{"date":47,"type":48},"2026-04-20","ACTUAL",{"date":50,"type":34},"2026-04",{"date":52,"type":34},"2028-04",{"name":5,"class":6}]