System Lupus Erythematosus(SLE)NCT07314567
ACE1831 in Adult Subjects With Relapsed/Refractory Systemic Lupus Erythematosus （SLE）
A study testing ACE1831 and Lymphodepleting chemotherapy in people with System Lupus Erythematosus(SLE), run by Tongji Hospital at 1 site in China.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- System Lupus Erythematosus(SLE)
- What is being tested?
- ACE1831 and Lymphodepleting chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
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)
- Conditions
- System Lupus Erythematosus(SLE)
- Being tested
- ACE1831, Lymphodepleting chemotherapy
- Keywords
- ACE1831, SLE, Refractory Systemic lupus erythematosus (SLE), gamma delta T (gdT) cell
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE1831Drug
ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort.
Lymphodepleting chemotherapyDrug
Subjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration.
| Study group | Role | What they receive |
|---|---|---|
| Participant | Experimental | 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 Receives: Drug: ACE1831; Drug: Lymphodepleting chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 weeks after last dose of ACE1831
Secondary outcomes (13)
To assess the efficacy of ACE1831： Changes in SLE disease activity Index (SLEDAI-2000) score
Changes of SLE disease activity Index (SLEDAI-2000) score
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831 ：Changes in BILAG-2004 score
Changes of BILAG-2004 score
Measured: 24 weeks after last dose of ACE1831
To assess the efficacy of ACE1831: LLDAS rate
Proportions of subjects achieving LLDAS by timepoint
Measured: 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
Measured: 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
Measured: 24 weeks after last dose of ACE1831
Persistence of ACE1831 after administration
Half-life of ACE1831
Measured: 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
Measured: 24 weeks after last dose of ACE1831
Immunogenicity
Titration of anti-ACE1831 antibodies after administration
Measured: 24 weeks after last dose of ACE1831
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for System Lupus Erythematosus(SLE)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingli Dong, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314567
- Sponsor's protocol ID
- ACE1831-301
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07314567
- Acronym / sponsor ID
- ACE1831-301
- Conditions
- System Lupus Erythematosus(SLE)
- Keywords
- ACE1831, SLE, Refractory Systemic lupus erythematosus (SLE), gamma delta T (gdT) cell
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | Experimental | Drug: ACE1831, Drug: Lymphodepleting chemotherapyThe 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE1831ACE1831 is allogeneic gamma delta T (gdT) cell therapy. Subjects will receive ACE1831 dose based on the assigned dose escalation cohort. | Drug | Participant |
| Lymphodepleting chemotherapySubjects assigned to receive lymphodepleting preconditioning (LDC) will receive chemotherapy cyclophosphamide ahead of ACE1831 administration. | Drug | Participant |
Primary outcome
To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus
Time frame: 24 weeks after last dose of ACE1831
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)
13 secondary outcomes
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
Immunogenicity
Time frame: 24 weeks after last dose of ACE1831
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACE1831 and Lymphodepleting chemotherapy in people with System Lupus Erythematosus(SLE), run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingli Dong (+862783665519, tjhdongll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus (time frame: 24 weeks after last dose of ACE1831). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.