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.