Refractory Active Systemic Lupus ErythematosusEarly Phase 1NCT07749430
A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus
A Early Phase 1 study testing ACG102 Injection in people with Refractory Active Systemic Lupus Erythematosus, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ACG102 administered via intravenous injection in patients with refractory active systemic lupus erythematosus (SLE) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Active Systemic Lupus Erythematosus
- What is being tested?
- ACG102 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 30 Jan 2028
- Phase
- Early Phase 1
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age at time of informed consent.
- Diagnosis of systemic lupus erythematosus (SLE) fulfilling the 2019 EULAR/ACR classification criteria.
- Refractory active disease defined as inadequate response to, or relapse following, standard of care (SoC) therapy.
- Patients on a stable dose of SoC for at least 4 weeks prior to enrollment.
- Sufficient organ function as defined by the protocol.
Who cannot join
- Active severe infection, including tuberculosis.
- Severe hypogammaglobulinemia or IgA deficiency.
- Active hepatitis or history of severe liver disease.
- Severe cardiovascular diseases.
- History of cancer within the past 5 years (with exceptions per protocol).
- Receipt of B-cell-targeted therapies or other biologic therapies within the defined washout window prior to enrollment.
- History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation.
- Known allergy to any active or inactive component of the study drug.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Characteristics, and Preliminary Efficacy of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ACG102 administered via intravenous injection in patients with refractory active systemic lupus erythematosus (SLE)
Read the detailed description
A first-in-human, open label study to evaluate safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of multiple ascending dose ACG102 intravenously administered to adult participants with refractory active systemic lupus erythematosus (SLE)
- Being tested
- ACG102 Injection
- Keywords
- ACG102-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACG102 InjectionDrug
All enrolled participants will receive multiple intravenous infusions of ACG102 at the dose level assigned to their cohort. Dose levels and dosing schedules may be adjusted based on emerging safety, tolerability, and PK/PD data.
| Study group | Role | What they receive |
|---|---|---|
| ACG102 | Experimental | Multiple escalating intravenous doses of ACG102 administered on pre-specified days to adult patients with refractory active SLE. Dose levels and schedules may be adjusted based on emerging safety, tolerability, and PK/PD data, followed by a safety and efficacy follow-up period. Receives: Drug: ACG102 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Number and proportion of participants experiencing DLT. A DLT is defined as any treatment-emergent adverse event (TEAE) occurring within the 21-day DLT evaluation period post-infusion that meets protocol-specified criteria, graded per NCI CTCAE v5.0 and ASTCT consensus criteria for CRS and ICANS, and is considered at least possibly related to the study intervention
Measured: Within 21 days after first dose
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Percentage of participants experiencing TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) graded per NCI CTCAE v5.0 and ASTCT consensus criteria
Measured: From first dose through Week 52
Incidence of Treatment-Emergent Clinical Laboratory Abnormalities
Number of participants with clinically significant shifts from baseline in safety laboratory assessments (hematology, liver enzymes, coagulation, and vital sign)
Measured: Up to 52 weeks post first dose
Secondary outcomes (17)
Change from baseline in SLE disease activity scores
Change from baseline will be calculated as the score at each post-baseline visit minus the score at baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Measured: baseline and up to Week 52 post first dose
Change from Baseline in BILAG-2004 Score
Change from baseline will be calculated as the total score at each post-baseline visit minus the score at baseline of the British Isles Lupus Assessment Group 2004 Index (BILAG-2004)
Measured: pre-dose and up to 52 weeks post the first dose
Change from Baseline in Physician's Global Assessment (PGA) Score
Change from baseline will be calculated as the score at each post-baseline visit minus the score at baseline of PGA score
Measured: pre-dose and up to 52 weeks post first dose
Composite efficacy response rates
Proportion of participants achieving the SLE Responder Index-4 (SRI-4) response
Measured: baseline and up to Week 52 post first dose
Composite efficacy response rates
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)
Measured: baseline and up to Week 52 post first dose
Composite efficacy response rates
Proportion of participants achieving the Definition Of Remission In SLE (DORIS).
Measured: Baseline and up to Week 52 post first dose
Change from baseline in SF-36 score
Change from baseline in 36-Item Short-Form Health Survey (SF-36) score.
Measured: baseline and up to Week 52 post first dose
Change from baseline in renal parameters
Urine protein will be quantified from a 24-hour urine collection at each scheduled visit, expressed in grams per 24 hours (g/24h). Change from baseline will be calculated as the value at each post-baseline visit minus the value at baseline
Measured: Baseline and up to Week 52 post first dose
Change from baseline in renal parameters
Change from Baseline in Urine Protein-to-Creatinine Ratio (UPCR).Change from baseline will be calculated as the value at each post-baseline visit minus the value at baseline.
Measured: Baseline and up to Week 52 post first dose
Change from baseline in renal parameters
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) by CKD-EPI;Change from baseline will be calculated as the value at each post-baseline visit minus the value at baseline.
Measured: baseline and up to Week 52 post first dose
Change from baseline in renal parameters
Proportion of participants with baseline proteinuria >0.5 g/24h achieving proteinuria negativity.
Measured: Baseline and up to Week 52 post first dose
Pharmacokinetic profiling
Quantification of Target mRNA Expression Levels in Biological Samples via RT-qPCR.
Measured: Baseline and up to 24 weeks post first dose
Pharmacokinetics measurement
Bioanalytical Quantification of Cationic Lipids and Major Metabolites using LC/MS
Measured: baseline and up to 24 weeks post first dose
Pharmacodynamic Profiling
Serum concentrations of the TCE protein will be evaluated using a validated Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: Baseline and up to 24 weeks post first dose
Pharmacodynamic biomarkers
Changes from baseline in serum IgG, IgM, IgA, anti-dsDNA antibodies, complement C3, and complement C4.
Measured: Baseline and up to 52 weeks post first dose
Immunogenicity
Percentage of participants who develop treatment-induced or treatment-enhanced ADAs and subsequent NAbs against ACG102 as determined by validated immunoassays.
Measured: Baseline and up to 52 weeks post first dose
Immunogenicity
Percentage of participants with detectable antibodies directed against the PEG component of the formulation, measured via validated serum assays.
Measured: Baseline and up to 52 weeks post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Active Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749430
- Sponsor's protocol ID
- ACG102-001
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No