ACE1831: ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Lymphodepleting chemotherapy: Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
Study 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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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)
* Received any B-cell depletion biologic therapy
* Received immunosuppressive small molecule drug therapy, or other systemic corticosteroid therapy , or prednisone
* Pregnant or lactating women
Primary outcome measure(s)
To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus — 24 weeks after last dose of ACE1831 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)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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