An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.
详细描述
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory systemic lupus erythematosus. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Active infections such as hepatitis and tuberculosis.
- •Other autoimmune diseases.
- •Serious underlying diseases such as tumor, uncontrolled diabetes.
- •Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
- •Participated in other clinical trials within
研究组 & 干预措施
LCAR-AIO T Cells
Experimental: Chimeric antigen receptor T cells (LCAR-AIO)
Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level
干预措施: LCAR-AIO T cells (Biological)
结局指标
主要结局
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
时间窗: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Incidence of dose-limiting toxicity (DLT)
时间窗: 30 days after LCAR-AIO infusion (Day 1)
DLTs are severe adverse events refers to any untoward medical occurred in a subject participated in a clinical investigation, which have a causal relationship with the treatment and will limit the dose escalation.
Pharmacokinetics in peripheral blood
时间窗: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
CAR positive T cells levels in peripheral blood after LCAR-AIO infusion.
Recommended Phase 2 Dose (RP2D) regimen finding
时间窗: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
RP2D established through dose exploratory.
次要结局
- Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks(Minimum 104 Weeks after LCAR-AIO infusion (Day 1))
- Change in Physician global assessment (PGA) scores from baseline up to 104 weeks(Minimum 104 Weeks after LCAR-AIO infusion (Day 1))
- Lupus Low Disease Activity State (LLDAS) response rates at multiple visits post-infusion(Minimum 104 Weeks after LCAR-AIO infusion (Day 1))
- 24h urinary protein/urine protein-to-creatinine ratio (UPCR) changes from baseline up to 104 weeks(Minimum 104 Weeks after LCAR-AIO infusion (Day 1))
- Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody)(Time Frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1))
研究者
Qiubai Li
Professor
Wuhan Union Hospital, China