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)
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
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
Single group
ACE1831
DrugACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Lymphodepleting chemotherapy
DrugSubjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
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)
To assess the efficacy of ACE1831： Changes in SLE disease activity Index (SLEDAI-2000) score
Changes of SLE disease activity Index (SLEDAI-2000) score
To assess the efficacy of ACE1831 (secondary efficacy)：Changes in PGA
Changes in Physician's Global Assessment (PGA) of disease activity score (Visual Activity Score,scale range 0 - 100)
To assess the efficacy of ACE1831 : Changes in SGA
Changes in Subject's Global Assessment (SGA) of disease activity score (Visual Activity Score,scale range 0 - 100)
To assess the efficacy of ACE1831 ：Changes in LupusQOL
Changes of Lupus Qualituy of Life(LupusQOL) total score
To assess the efficacy of ACE1831： single-cell sequencing
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