ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）
NCT ID: NCT07314567
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
22 participants
INTERVENTIONAL
2026-01-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participant
The single, open label study arm includes 2 dose escalation cohorts:
Cohort 1: Receives ACE1831 (Dose Level 1) with LDC depending on assignment Cohort 2: Receives ACE1831 (Dose Level 2) with LDC depending on assignment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Lingli Dong
Director of the department of rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Tongji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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ACE1831-301
Identifier Type: -
Identifier Source: org_study_id
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