A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus

NCT07749430 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ACG102-001
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Refractory Active Systemic Lupus Erythematosus

Keywords

ACG102-001

Outcome Measures

Primary Outcomes (3)

• 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

  Within 21 days after first dose

• 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

  From first dose through Week 52

• 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)

  Up to 52 weeks post first dose

Secondary Outcomes (17)

• Change from baseline in SLE disease activity scores

  baseline and up to Week 52 post first dose

• Change from Baseline in BILAG-2004 Score

  pre-dose and up to 52 weeks post the first dose

• Change from Baseline in Physician's Global Assessment (PGA) Score

  pre-dose and up to 52 weeks post first dose

• Composite efficacy response rates

  baseline and up to Week 52 post first dose

• Composite efficacy response rates

  baseline and up to Week 52 post first dose

Study Arms (1)

ACG102

EXPERIMENTAL

Multiple escalating intravenous doses of ACG102 administered on pre-specified days to adult patients with refractory active SLE. Dose levels and schedules may be adjusted based on emerging safety, tolerability, and PK/PD data, followed by a safety and efficacy follow-up period.

Drug: ACG102 Injection

Interventions

ACG102 Injection DRUG

All 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.

ACG102

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.
• History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation.
• Known allergy to any active or inactive component of the study drug.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Central Study Contacts

qiubai li, archiater

CONTACT

027-85726808; liqiubai_hust@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share