[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-active-systemic-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-active-systemic-lupus-erythematosus":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"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":20,"type":21},13,"ESTIMATED","INTERVENTIONAL",[24],"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)",[27],"Refractory Active Systemic Lupus Erythematosus",[29],"ACG102-001","NOT_YET_RECRUITING","2026-08-03",{"date":33,"type":34},"2026-08-06","ACTUAL",{"date":36,"type":21},"2026-09-15",{"date":38,"type":21},"2028-01-30",{"name":40,"class":41},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100569442","phase-1-a-study-of-sys6020-injection-in-refractory-active-systemic-lupus-erythematosus-100569442","NCT06694298","A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus","A Phase I Clinical Study of BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection in Refractory Active Systemic Lupus Erythematosus Patients","Inclusion Criteria:\n\n* 1\\. Age ≥18 years old, ≤70 years old;\n* 2\\. SLE is diagnosed according to SLICC 2012 or EULAR\u002FACR 2019 revised criteria.\n* 3\\. Patients are required to have received glucocorticoid combined with immunosuppressive agents and\u002For biological agents for more than 3 months, with a stable dose for more than 2 weeks, and the disease is still in an active state.\n* 4\\. Antinuclear antibody, anti-ds-DNA antibody and\u002For anti-Smith antibody are positive.\n* 5\\. SLEDAI-2K score≥7.\n* 6\\. BILAG2004 meets one of the following two criteria:a）BILAG grade A is defined as ≥1 organ system；b）BILAG grade B is defined as ≥2 organ systems\n* 7\\. PGA \\> 1.0;\n\nExclusion Criteria:\n\n* 1\\. Severe lupus nephritis within 8 weeks before screening;\n* 2\\. SLE or non-SLE-related central nervous system disease or lesion within 8 weeks before screening;\n* 3\\. uncontrolled lupus crisis within 8 weeks before screening;\n* 4\\. clinically significant central nervous system diseases or pathological changes other than lupus before screening;\n* 5\\. vasculitis or inflammatory arthritis or skin disease other than SLE or at screening;\n* 6\\. complicated with other autoimmune diseases;\n* 7\\. A B-cell-targeting agent have been used or is planned to be used within 8 weeks before screening，\n* 8\\. received Renal Replacement Therapy（RRT）within 3 months before the screening period or anticipates the need for RRT during the study period;\n* 9\\. participants who will undergo major surgery or invasive intervention within 4 weeks prior to apheresis or plan for systemic or local tumor resection during the study period;\n* 10\\. participants with a known allergy, hypersensitivity, intolerance, or contraindications to SYS6020 or any component of the drugs that may be used in the study,\n* 11\\. active bacterial, fungal, or viral infection within 2 weeks before apheresis;",{"count":50,"type":21},50,[52],"PHASE1","This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and preliminly evaluate the clinical efficacy of this product,and explore the pharmacokinetics and immunogenicity of SYS6020 injection in those participants.",[27],"2024-11-17",{"date":57,"type":34},"2024-11-19",{"date":59,"type":21},"2024-12-26",{"date":61,"type":21},"2029-01-29",{"name":63,"class":64},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY"]