A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Hidradenitis Suppurativa
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Incidence, nature, and severity of adverse events [Safety and Tolerability]
研究概览
简要总结
This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown.
详细描述
The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of hidradenitis suppurativa. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Body mass index (BMI) ≤50 kg/m2, inclusive
- •Diagnosis of clinically active moderate-to-severe HS (Hurley Stage 2 or 3)
- •Total abscess or inflammatory nodule (AN) count of ≥5, affecting at least 2 distinct anatomic regions, with at least 1 accessible AN of adequate size for biopsy (diameter > 1 cm)
- •Total draining tunnel (dT) count of ≤20
- •Documented history of inadequate response or intolerance to at least a 3-month course of 1 conventional systemic therapy (e.g., antibiotic) and 1 biologic drug (e.g., adalimumab or secukinumab)
- •Doses of medications for HS must be stable for at least 5 weeks prior to study drug administration
- •Must agree to use highly effective method of contraception for at least 1 year post SBT777101 administration
排除标准
- •Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
- •History of or current inflammatory or other autoimmune disease
- •Complex presentations of HS
- •Skin disease other than HS that may confound clinical assessments or increase subject risk in the study
- •Uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
- •Active current infection or history of recurrent infections
- •Active or untreated latent tuberculosis
- •Primary or secondary immunodeficiency
研究组 & 干预措施
SBT777101 Dose Level 2
Mid dose SBT777101
干预措施: SBT777101 (Biological)
SBT777101 Dose Level 1
Low dose SBT777101
干预措施: SBT777101 (Biological)
SBT777101 Dose Level 3
High dose SBT777101
干预措施: SBT777101 (Biological)
结局指标
主要结局
Incidence, nature, and severity of adverse events [Safety and Tolerability]
时间窗: Day of treatment to end of follow-up period (48 weeks)
Incidence and nature of Dose Limiting Toxicities [DLTs]
时间窗: Day of treatment to end of DLT evaluation period (28 days)
次要结局
未报告次要终点