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)

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)

Study Overview

• Status: Not yet recruiting
• Conditions: System Lupus Erythematosus(SLE)
• Intervention / Treatment: Drug: ACE1831; Drug: Lymphodepleting chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lingli Dong; Phone Number: +862783665519; Email: tjhdongll@163.com
• Study Contact Backup: Name: Ziwei Hu; Phone Number: 13237100403; Email: 836048368@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital
      • Contact: Phone Number: 13237100403; Email: 836048368@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 weeks after last dose of ACE1831

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the efficacy of ACE1831： Changes in SLE disease activity Index (SLEDAI-2000) score	Changes of SLE disease activity Index (SLEDAI-2000) score	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)	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: 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	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	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	24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 ：Changes in BILAG-2004 score	Changes of BILAG-2004 score	24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831: LLDAS rate	Proportions of subjects achieving LLDAS by timepoint	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	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	24 weeks after last dose of ACE1831
Persistence of ACE1831 after administration	Half-life of ACE1831	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	24 weeks after last dose of ACE1831
Immunogenicity	Titration of anti-ACE1831 antibodies after administration	24 weeks after last dose of ACE1831

Other Outcome Measures

Outcome Measure	Time Frame
To assess the efficacy of ACE1831： single-cell sequencing	24 weeks after last dose of ACE1831

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: SLE; ACE1831; Refractory Systemic lupus erythematosus (SLE); gamma delta T (gdT) cell
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: ACE1831-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No