[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617126":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":51,"collaborators":21,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":21,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":21,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":77,"whyStopped":21,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participant","EXPERIMENTAL","The single, open label study arm includes 2 dose escalation cohorts:\n\nCohort 1: Receives ACE1831 (Dose Level 1) with LDC depending on assignment Cohort 2: Receives ACE1831 (Dose Level 2) with LDC depending on assignment",[13,14],"Drug: ACE1831","Drug: Lymphodepleting chemotherapy",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","ACE1831","ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Lymphodepleting chemotherapy","Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Lingli Dong","CONTACT","+862783665519","tjhdongll@163.com",{"name":33,"role":29,"phone":34,"phoneExt":21,"email":35},"Ziwei Hu","13237100403","836048368@qq.com",[37],{"facility":5,"status":21,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Wuhan","Hubei","430030","China","CN",{"type":44,"coordinates":45},"Point",[46,47],114.26667,30.58333,{"lat":47,"lon":46},[50],{"name":21,"role":29,"phone":34,"phoneExt":21,"email":35},{"type":52,"investigatorFullName":28,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Director of the department of rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","100617126","ace1831-in-adult-subjects-with-relapsedrefractory-systemic-lupus-erythematosus-sle-100617126",false,"NCT07314567","ACE1831 in Adult Subjects With Relapsed\u002FRefractory Systemic Lupus Erythematosus （SLE）","An Open Label, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Relapsed\u002FRefractory Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n* Male or female 18 to 60 years (inclusive)\n* History of meeting the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) criteria, or the 1997 ACR criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC)\n* Presence of anti-dsDNA antibodies and\u002For anti-nuclear antibodies (ANA) and\u002For anti-Smith (anti-Sm) antibodies positive\n* SLE is in the moderate to severe active phase with the SLEDAI-2000 score ≥ 8\n* At least one British Isle Lupus Rating Group Index (BILAG-2004) Class A (severe manifestation) or two Class B (moderate manifestation) organ scores, or both\n* Inadequate response to glucocorticoids and at least 2 of treatments used for at least 3 months\n* Women of childbearing potential and their partners must agree to use at least 1 highly effective method of contraception throughout the study period and for 1 year after treatment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe lupus nephritis requiring prohibited medications for active nephritis treatment，or hemodialysis, or eGFR \\\u003C 50 ml\u002Fmin\u002F1.73m²\n* Central nervous system disease caused by SLE or other conditions\n* Significant medical history that would pose a risk to the patients safety from the investigator's opinion, or patients medical condition could worsen during the study\n* Malignancies within 5 years\n* Presence of active, recurrent, chronic infection requiring treatment , or latent infection (HBV, HCV, HIV, TB, syphilis)\n* Received any B-cell depletion biologic therapy\n* Received immunosuppressive small molecule drug therapy， or other systemic corticosteroid therapy ， or prednisone\n* Pregnant or lactating women","ALL","18 Years","60 Years",{"count":65,"type":66},22,"ESTIMATED","INTERVENTIONAL",[69],"NA","ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Relapsed\u002FRefractory Systemic lupus erythematosus (SLE)",[72],"System Lupus Erythematosus(SLE)",[18,74,75,76],"SLE","Refractory Systemic lupus erythematosus (SLE)","gamma delta T (gdT) cell","NOT_YET_RECRUITING","2025-12-17",{"date":80,"type":81},"2026-01-02","ACTUAL",{"date":83,"type":66},"2026-01-01",{"date":85,"type":66},"2027-12-31",{"name":5,"class":6},1]