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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 13
- 主要终点
- Incidence of dose-limiting toxicities (DLTs)
研究概览
简要总结
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)
详细描述
A first-in-human, open label study to evaluate safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of multiple ascending dose ACG102 intravenously administered to adult participants with refractory active systemic lupus erythematosus (SLE)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
研究组 & 干预措施
ACG102
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.
干预措施: ACG102 Injection (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs)
时间窗: Within 21 days after first dose
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
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: From first dose through Week 52
Percentage of participants experiencing TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) graded per NCI CTCAE v5.0 and ASTCT consensus criteria
Incidence of Treatment-Emergent Clinical Laboratory Abnormalities
时间窗: Up to 52 weeks post first dose
Number of participants with clinically significant shifts from baseline in safety laboratory assessments (hematology, liver enzymes, coagulation, and vital sign)
次要结局
- 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)
- Change from baseline in SF-36 score(baseline and up to Week 52 post first dose)
- Change from baseline in renal parameters(Baseline and up to Week 52 post first dose)
- Change from baseline in renal parameters(baseline and up to Week 52 post first dose)
- Pharmacokinetic profiling(Baseline and up to 24 weeks post first dose)
- Pharmacokinetics measurement(baseline and up to 24 weeks post first dose)
- Pharmacodynamic Profiling(Baseline and up to 24 weeks post first dose)
- Pharmacodynamic biomarkers(Baseline and up to 52 weeks post first dose)
- Immunogenicity(Baseline and up to 52 weeks post first dose)
研究者
Qiubai Li
Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology