NCT07749430Not yet recruitingEarly phase 1
A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 5 Jun 2026
- Start date
- 15 Sept 2026
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Lupus (SLE)
- NCT number
- NCT07749430
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 13
- From 15 Sept 2026 to the primary completion date, 30 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of B-cell-targeted therapies or other biologic therapies within the defined washout window prior to enrollment.
Other illness
- Active severe infection, including tuberculosis.
- Active hepatitis or history of severe liver disease.
- Severe cardiovascular diseases.
- History of cancer within the past 5 years (with exceptions per protocol).
- History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation.
- Known allergy to any active or inactive component of the study drug.
Other
- Severe hypogammaglobulinemia or IgA deficiency.
Who the study is looking for
- ≥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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.