A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus (NCT07749430) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus
13 participantsStarted 2026-09-15
Plain-language 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)
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose-limiting toxicities (DLTs)
Timeframe: Within 21 days after first dose
2
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: From first dose through Week 52
3
Incidence of Treatment-Emergent Clinical Laboratory Abnormalities
Timeframe: Up to 52 weeks post first dose
Trial details
NCT IDNCT07749430
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology