About this trial
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)
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ACE1831
- Lymphodepleting chemotherapy