NCT07314567Not yet recruiting
ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）
An Open Label, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Tongji Hospital
- Diseases
- Lupus (SLE)
- NCT number
- NCT07314567
What you commit to
- Study type: Interventional
- Planned participants: 22
- From 1 Jan 2026 to the primary completion date, 30 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received any B-cell depletion biologic therapy
- Received immunosuppressive small molecule drug therapy， or other systemic corticosteroid therapy ， or prednisone
Other illness
- 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)
Lab values
- Severe lupus nephritis requiring prohibited medications for active nephritis treatment，or hemodialysis, or eGFR \< 50 ml/min/1.73m²
Other
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.