NCT06038474进行中（未招募）2 期
Descartes-08 for Patients With Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)
研究概览
简要总结
This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least 18 years of age.
- •Patient must have systemic lupus erythematosus (SLE) at the time of screening.
- •Active symptoms despite recent or ongoing immunosuppressive therapy with glucocorticoids and at least 2 other immunosuppressive medications being tried for at least 12 weeks within 24 months of screening.
- •At least one of: anti-dsDNA, anti-histone, anti-chromatin, and/or anti-Sm antibodies detectable at screening as assessed by a CLIA-certified laboratory.
排除标准
- •Active severe lupus nephritis, active severe CNS lupus, and/or neurological symptoms of SLE including headache, seizure, psychosis, and organic brain syndrome (a patient with an incidental headache, deemed unrelated to SLE, may re-screen by telephone upon resolution of the headache);
- •Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient.
- •Patient is pregnant or lactating.
研究组 & 干预措施
Descartes-08
Other
Drug: Descartes-08
Autologous T-cells expressing a chimeric antigen receptor directed to BCMA
干预措施: Descartes-08 (Drug)
结局指标
主要结局
Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)
时间窗: Day -59 to Day 50
Results will be descriptive. Safety and tolerability endpoints will include descriptive statistics of AEs and SAEs. Patients must be followed until all AEs have resolved to Grade 2 or less except for lymphopenia and alopecia.
次要结局
- Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)(Day -59 to Month 12)
- Assess the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI)(Day -59 to Month 12)
- Assess the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)(Day -59 to Month 12)
- Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA)(Day -59 to Month 12)
研究者
研究点 (1)
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