ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE) (NCT07314567) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
China22 participantsStarted 2026-01-01
Plain-language 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)
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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)
* Recei…
What they're measuring
1
To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus