An interventional study of ACE1831 and Lymphodepleting chemotherapy in System Lupus Erythematosus(SLE), sponsored by Tongji Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment
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)
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 22 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: ACE1831 · Drug: Lymphodepleting chemotherapy
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus
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)
Time frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831： Changes in SLE disease activity Index (SLEDAI-2000) score
Changes of 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
Changes in Physician's Global Assessment (PGA) of disease activity score (Visual Activity Score,scale range 0 - 100)
Time frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 : Changes in SGA
Changes in Subject's Global Assessment (SGA) of disease activity score (Visual Activity Score,scale range 0 - 100)
Time frame: Time Frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 ：Changes in LupusQOL
Changes of Lupus Qualituy of Life(LupusQOL) total score
Time frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 ：Changes in EQ-5D-5L score
Changes of European Quality of Life Five Dimension Five Level questionnaire(EQ-5D-5L )score
Time frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 ：Changes in SF-12 score
Changes in Quality of Life Questionnaire (QOL) Short Form 12 (SF-12) total score
Time frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 ：Changes in BILAG-2004 score
Changes of BILAG-2004 score
Time frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831: LLDAS rate
Proportions of subjects achieving LLDAS by timepoint
Time frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831: DORIS
Proportions of subjects who achieved remission according to the DORIS by timepoint
Time frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831: SRI-4 response rate
Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response
Time frame: 24 weeks after last dose of ACE1831
Persistence of ACE1831 after administration
Half-life of ACE1831
Time frame: 8 weeks after last dose of ACE1831
Measure the pharmacodynamics change of ACE1831
Immunoglobulin, cytokines, lymphocytecount , autoantibody titers, complement C3 and C4 levels, C-reactive protein, erythrocyte sedimentation rate, etc
Time frame: 24 weeks after last dose of ACE1831
Immunogenicity
Titration of anti-ACE1831 antibodies after administration
Time frame: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831： single-cell sequencing
Time frame: 24 weeks after last dose of ACE1831
Plan to share: No
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Lupus Erythematosus, Systemic→
Tongji Hospital