Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:24 AM
Study NCT ID:
NCT07314567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To assess the efficacy of ACE1831： single-cell sequencing', 'timeFrame': '24 weeks after last dose of ACE1831'}], 'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'To assess the incidence of Adverse Events (AEs), \\[AEs including Treatment Emergent AEs, Serious AEs (SAEs), AEs of Special Interests (AESIs), and dose limiting toxicities (DLTs)\\] (unit: number of AEs)'}], 'secondaryOutcomes': [{'measure': 'To assess the efficacy of ACE1831： Changes in SLE disease activity Index (SLEDAI-2000) score', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Changes of SLE disease activity Index (SLEDAI-2000) score'}, {'measure': 'To assess the efficacy of ACE1831 (secondary efficacy)：Changes in PGA', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': "Changes in Physician's Global Assessment (PGA) of disease activity score (Visual Activity Score,scale range 0 - 100)"}, {'measure': 'To assess the efficacy of ACE1831 : Changes in SGA', 'timeFrame': 'Time Frame: 24 weeks after last dose of ACE1831', 'description': "Changes in Subject's Global Assessment (SGA) of disease activity score (Visual Activity Score,scale range 0 - 100)"}, {'measure': 'To assess the efficacy of ACE1831 ：Changes in LupusQOL', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Changes of Lupus Qualituy of Life(LupusQOL) total score'}, {'measure': 'To assess the efficacy of ACE1831 ：Changes in EQ-5D-5L score', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Changes of European Quality of Life Five Dimension Five Level questionnaire(EQ-5D-5L )score'}, {'measure': 'To assess the efficacy of ACE1831 ：Changes in SF-12 score', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Changes in Quality of Life Questionnaire (QOL) Short Form 12 (SF-12) total score'}, {'measure': 'To assess the efficacy of ACE1831 ：Changes in BILAG-2004 score', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Changes of BILAG-2004 score'}, {'measure': 'To assess the efficacy of ACE1831: LLDAS rate', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Proportions of subjects achieving LLDAS by timepoint'}, {'measure': 'To assess the efficacy of ACE1831: DORIS', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Proportions of subjects who achieved remission according to the DORIS by timepoint'}, {'measure': 'To assess the efficacy of ACE1831: SRI-4 response rate', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response'}, {'measure': 'Persistence of ACE1831 after administration', 'timeFrame': '8 weeks after last dose of ACE1831', 'description': 'Half-life of ACE1831'}, {'measure': 'Measure the pharmacodynamics change of ACE1831', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Immunoglobulin, cytokines, lymphocytecount , autoantibody titers, complement C3 and C4 levels, C-reactive protein, erythrocyte sedimentation rate, etc'}, {'measure': 'Immunogenicity', 'timeFrame': '24 weeks after last dose of ACE1831', 'description': 'Titration of anti-ACE1831 antibodies after administration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACE1831', 'SLE', 'Refractory Systemic lupus erythematosus (SLE)', 'gamma delta T (gdT) cell'], 'conditions': ['System Lupus Erythematosus(SLE)']}, 'descriptionModule': {'briefSummary': '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/Refractory Systemic lupus erythematosus (SLE)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female 18 to 60 years (inclusive)\n* History of meeting the 2019 European League Against Rheumatism (EULAR)/American 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/or anti-nuclear antibodies (ANA) and/or 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 \\< 50 ml/min/1.73m²\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"}, 'identificationModule': {'nctId': 'NCT07314567', 'briefTitle': 'ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'An Open Label, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)', 'orgStudyIdInfo': {'id': 'ACE1831-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participant', 'description': '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', 'interventionNames': ['Drug: ACE1831', 'Drug: Lymphodepleting chemotherapy']}], 'interventions': [{'name': 'ACE1831', 'type': 'DRUG', 'description': 'ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.', 'armGroupLabels': ['Participant']}, {'name': 'Lymphodepleting chemotherapy', 'type': 'DRUG', 'description': 'Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.', 'armGroupLabels': ['Participant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'role': 'CONTACT', 'email': '836048368@qq.com', 'phone': '13237100403'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Lingli Dong', 'role': 'CONTACT', 'email': 'tjhdongll@163.com', 'phone': '+862783665519'}, {'name': 'Ziwei Hu', 'role': 'CONTACT', 'email': '836048368@qq.com', 'phone': '13237100403'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the department of rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'investigatorFullName': 'Lingli Dong', 'investigatorAffiliation': 'Tongji Hospital'}}}}