NCT06694298尚未招募1 期
A Phase I Clinical Study of BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection in Refractory Active Systemic Lupus Erythematosus Patients
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.0 个研究点目标入组 50 人开始时间: 2024年12月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- The frequency and nature of DLT and the incidence of all adverse events and serious adverse events
研究概览
简要总结
This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and preliminly evaluate the clinical efficacy of this product,and explore the pharmacokinetics and immunogenicity of SYS6020 injection in those participants.
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
- •Age ≥18 years old, ≤70 years old;
- •SLE is diagnosed according to SLICC 2012 or EULAR/ACR 2019 revised criteria.
- •Patients are required to have received glucocorticoid combined with immunosuppressive agents and/or biological agents for more than 3 months, with a stable dose for more than 2 weeks, and the disease is still in an active state.
- •Antinuclear antibody, anti-ds-DNA antibody and/or anti-Smith antibody are positive.
- •SLEDAI-2K score≥
- •BILAG2004 meets one of the following two criteria:a）BILAG grade A is defined as ≥1 organ system；b）BILAG grade B is defined as ≥2 organ systems
- •PGA > 1.0;
排除标准
- •Severe lupus nephritis within 8 weeks before screening;
- •SLE or non-SLE-related central nervous system disease or lesion within 8 weeks before screening;
- •uncontrolled lupus crisis within 8 weeks before screening;
- •clinically significant central nervous system diseases or pathological changes other than lupus before screening;
- •vasculitis or inflammatory arthritis or skin disease other than SLE or at screening;
- •complicated with other autoimmune diseases;
- •A B-cell-targeting agent have been used or is planned to be used within 8 weeks before screening，
- •received Renal Replacement Therapy（RRT）within 3 months before the screening period or anticipates the need for RRT during the study period;
- •participants who will undergo major surgery or invasive intervention within 4 weeks prior to apheresis or plan for systemic or local tumor resection during the study period;
- •participants with a known allergy, hypersensitivity, intolerance, or contraindications to SYS6020 or any component of the drugs that may be used in the study,
- •active bacterial, fungal, or viral infection within 2 weeks before apheresis;
研究组 & 干预措施
SYS6020
Experimental
干预措施: SYS6020 (Drug)
结局指标
主要结局
The frequency and nature of DLT and the incidence of all adverse events and serious adverse events
时间窗: 28 days after infusion
Assess safety and tolerability of SYS6020 in patients with systemic lupus erythematosus
recommended dose (RD)
时间窗: 6 Months
recommended dose (RD)
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS).
时间窗: 6 Months
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS) at 6 months.
次要结局
- Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)(12 weeks)
- Proportion of participants with complete reduction of hormone dose(6 Months)
- Proportion of participants taking ≤5mg/ day of hormone(6 Months)
- Proportion of participants achieving low disease activity status (LLDAS)(12weeks、6 Months)
- Absolute and percentage changes from baseline in SLEDA1-2K, BILAG-2004 and PGA scores(6 Months)
- Changes from baseline in antinuclear antibody, anti-ds-DNA antibody, anti-Smith antibody, C3, C4, and 24-hour urinary protein(6 Months)
- Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline(6 Months)
- Change from baseline in SF-36(6 Months)
- BCMA CAR+ gene copy numberCAR gene copies(6 Months)
- Number of CAR+ cells(6 Months)
- Incidence of all adverse events and serious adverse events(6 Months)
研究者
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