NCT07749430
A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus
Not Yet Recruiting · Early Phase 1 · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · registry updated 2026-08-06
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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)
Inclusion
- ≥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.
Exclusion
- 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.