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)
≥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.
Active severe infection, including tuberculosis.
Severe hypogammaglobulinemia or IgA deficiency.
Active hepatitis or history of severe liver disease.
Severe cardiovascular diseases.
Single group
ACG102 Injection
DrugAll 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.
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
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
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)
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)
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)
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
Composite efficacy response rates
Proportion of participants achieving the SLE Responder Index-4 (SRI-4) response
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