Tests ACE1831 donor cell therapy in adults with relapsed or hard-to-treat lupus
Tests ACE1831, donor-derived immune cells, in adults with lupus that returned or did not respond.
Plain-language title generated from the registry record
Registry title: ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）
Key facts
- Where
- Wuhan, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07314567, who can take part
Where in China
- Tongji HospitalWuhan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tongji Hospital
- Trial code
- NCT07314567
- Record updated
- 2 January 2026
- Original description
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)Read full original descriptionShow less
An Open Label, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
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)
Inclusion: 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.
Exclusion: Received any B-cell depletion biologic therapy; Received immunosuppressive small molecule drug therapy， or other systemic corticosteroid therapy ， or prednisone; 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); Severe lupus nephritis requiring prohibited medications for active nephritis treatment，or hemodialysis, or eGFR < 50 ml/min/1.73m²; Pregnant or lactating women.