ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTongji Hospital

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

Treatment groups

22 Participants
are divided into 1 treatment group

Sponsors and collaborators