Not yet recruiting NCT07314567
ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACE1831, Lymphodepleting chemotherapy.
- Who it may be relevant to
- Registry conditions: System Lupus Erythematosus(SLE). Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open Label, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
Overview
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)
Interventions
- Drug ACE1831
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort. - Drug Lymphodepleting chemotherapy
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
Primary outcome measures
- To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus [Time frame: 24 weeks after last dose of ACE1831]
Secondary outcome measures (12)
- To assess the efficacy of ACE1831： Changes in SLE disease activity Index (SLEDAI-2000) score [Time frame: 24 weeks after last dose of ACE1831]
- To assess the efficacy of ACE1831 (secondary efficacy)：Changes in PGA [Time frame: 24 weeks after last dose of ACE1831]
- To assess the efficacy of ACE1831 : Changes in SGA [Time frame: Time Frame: 24 weeks after last dose of ACE1831]
- To assess the efficacy of ACE1831 ：Changes in LupusQOL [Time frame: 24 weeks after last dose of ACE1831]
- To assess the efficacy of ACE1831 ：Changes in EQ-5D-5L score [Time frame: 24 weeks after last dose of ACE1831]
- To assess the efficacy of ACE1831 ：Changes in SF-12 score [Time frame: 24 weeks after last dose of ACE1831]
- To assess the efficacy of ACE1831 ：Changes in BILAG-2004 score [Time frame: 24 weeks after last dose of ACE1831]
- To assess the efficacy of ACE1831: LLDAS rate [Time frame: 24 weeks after last dose of ACE1831]
- To assess the efficacy of ACE1831: DORIS [Time frame: 24 weeks after last dose of ACE1831]
- To assess the efficacy of ACE1831: SRI-4 response rate [Time frame: 24 weeks after last dose of ACE1831]
- Persistence of ACE1831 after administration [Time frame: 8 weeks after last dose of ACE1831]
- Measure the pharmacodynamics change of ACE1831 [Time frame: 24 weeks after last dose of ACE1831]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital — Wuhan
Identifiers
NCT: NCT07314567 · ACE1831-301