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Clinical Trials in China / NCT07314567
Starting soon Not applicable

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

NCT07314567 · tracked via the Priya Life Science China tracker
Sponsor
Tongji Hospital
Phase
Not applicable
Started
2026-01-01
Last updated
2026-01-02

Condition(s) studied

System Lupus Erythematosus(SLE)

Investigational drug(s) / intervention(s)

ACE1831Lymphodepleting chemotherapy

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)

Trial sites (1)

FacilityCityRegionStatus
Tongji Hospital Wuhan Hubei

More Tongji Hospital trials in China

Other trials for the same condition

Official registry record

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.

View NCT07314567 on ClinicalTrials.gov ↗ ← All trials in China