[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650639":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":20,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":20},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ACG102","EXPERIMENTAL","Multiple escalating intravenous doses of ACG102 administered on pre-specified days to adult patients with refractory active SLE. Dose levels and schedules may be adjusted based on emerging safety, tolerability, and PK\u002FPD data, followed by a safety and efficacy follow-up period.",[13],"Drug: ACG102 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","ACG102 Injection","All enrolled participants will receive multiple intravenous infusions of ACG102 at the dose level assigned to their cohort. Dose levels and dosing schedules may be adjusted based on emerging safety, tolerability, and PK\u002FPD data.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"qiubai li, archiater","CONTACT","027-85726808","liqiubai_hust@hust.edu.cn",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Qiubai Li","Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital","100650639","early-phase-1-a-clinical-study-of-acg102-injection-in-patients-with-refractory-active-systemic-lupus-erythematosus-100650639",false,"NCT07749430","A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus","A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Characteristics, and Preliminary Efficacy of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus","Key Inclusion Criteria:\n\n1. ≥18 years of age at time of informed consent.\n2. Diagnosis of systemic lupus erythematosus (SLE) fulfilling the 2019 EULAR\u002FACR classification criteria.\n3. Refractory active disease defined as inadequate response to, or relapse following, standard of care (SoC) therapy.\n4. Patients on a stable dose of SoC for at least 4 weeks prior to enrollment.\n5. Sufficient organ function as defined by the protocol.\n\nKey Exclusion Criteria:\n\n1. Active severe infection, including tuberculosis.\n2. Severe hypogammaglobulinemia or IgA deficiency.\n3. Active hepatitis or history of severe liver disease.\n4. Severe cardiovascular diseases.\n5. History of cancer within the past 5 years (with exceptions per protocol).\n6. Receipt of B-cell-targeted therapies or other biologic therapies within the defined washout window prior to enrollment.\n7. History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation.\n8. Known allergy to any active or inactive component of the study drug.","ALL","18 Years","70 Years",{"count":42,"type":43},13,"ESTIMATED","INTERVENTIONAL",[46],"EARLY_PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ACG102 administered via intravenous injection in patients with refractory active systemic lupus erythematosus (SLE)",[49],"Refractory Active Systemic Lupus Erythematosus",[51],"ACG102-001","NOT_YET_RECRUITING","2026-08-03",{"date":55,"type":56},"2026-08-06","ACTUAL",{"date":58,"type":43},"2026-09-15",{"date":60,"type":43},"2028-01-30",{"name":5,"class":6}]