ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）
An Open Label, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
1 other identifier
interventional
22
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
January 2, 2026
December 1, 2025
1.8 years
November 26, 2025
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus
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)
24 weeks after last dose of ACE1831
Secondary Outcomes (13)
To assess the efficacy of ACE1831： Changes in SLE disease activity Index (SLEDAI-2000) score
24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 (secondary efficacy)：Changes in PGA
24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 : Changes in SGA
Time Frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 ：Changes in LupusQOL
24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 ：Changes in EQ-5D-5L score
24 weeks after last dose of ACE1831
- +8 more secondary outcomes
Other Outcomes (1)
To assess the efficacy of ACE1831： single-cell sequencing
24 weeks after last dose of ACE1831
Study Arms (1)
Participant
EXPERIMENTALThe single, open label study arm includes 2 dose escalation cohorts: Cohort 1: Receives ACE1831 (Dose Level 1) with LDC depending on assignment Cohort 2: Receives ACE1831 (Dose Level 2) with LDC depending on assignment
Interventions
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
Eligibility Criteria
You may qualify if:
- Male or female 18 to 60 years (inclusive)
- 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)
- Presence of anti-dsDNA antibodies and/or anti-nuclear antibodies (ANA) and/or anti-Smith (anti-Sm) antibodies positive
- SLE is in the moderate to severe active phase with the SLEDAI-2000 score ≥ 8
- 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
- Inadequate response to glucocorticoids and at least 2 of treatments used for at least 3 months
- 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
- Signed informed consent
You may not qualify if:
- Severe lupus nephritis requiring prohibited medications for active nephritis treatment，or hemodialysis, or eGFR \< 50 ml/min/1.73m²
- Central nervous system disease caused by SLE or other conditions
- 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
- Malignancies within 5 years
- Presence of active, recurrent, chronic infection requiring treatment , or latent infection (HBV, HCV, HIV, TB, syphilis)
- Received any B-cell depletion biologic therapy
- Received immunosuppressive small molecule drug therapy， or other systemic corticosteroid therapy ， or prednisone
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the department of rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Record Dates
First Submitted
November 26, 2025
First Posted
January 2, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
October 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share