A Phase 1 Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults With Treatment-refractory Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
研究概览
简要总结
ADI-001-106 is a phase 1 study of ADI-001 with a randomized, single-blind, parallel group design to compare two different LD regimens in subjects with treatment-refractory RA. The study will consist of different periods including screening, LD, treatment, and follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age.
- •Fulfills the 2010 ACR-EULAR RA classification criteria
- •Agreement not to take traditional medicines and medications not prescribed by a doctor
- •Adequate hematological, liver, cardiac and pulmonary function
排除标准
- •Presence of severe liver disease, Child-Pugh class B or C.
- •Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent).
- •Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol)
- •History of a clinically significant infection (including sepsis, pneumonia, bacteremia, fungal, viral and opportunistic infections) within 4 weeks prior to first dose of study drug which in the opinion of the Investigator may compromise the safety of the subject in the study.
研究组 & 干预措施
Experimental: Run-in
干预措施: Fludarabine (Drug)
Experimental: Run-in
干预措施: Cyclophosphamide (Drug)
Experimental: Part 1a
Cy/Flu LD
干预措施: ADI-001 (Drug)
Experimental: Part 1a
Cy/Flu LD
干预措施: Fludarabine (Drug)
Experimental: Part 1a
Cy/Flu LD
干预措施: Cyclophosphamide (Drug)
Experimental: Part 1b
Cy-only LD
干预措施: ADI-001 (Drug)
Experimental: Part 1b
Cy-only LD
干预措施: Cyclophosphamide (Drug)
Experimental: Part 2a
Cy/Flu LD
干预措施: ADI-001 (Drug)
Experimental: Part 2a
Cy/Flu LD
干预措施: Fludarabine (Drug)
Experimental: Part 2a
Cy/Flu LD
干预措施: Cyclophosphamide (Drug)
Experimental: Part 2b
Cy-only LD
干预措施: ADI-001 (Drug)
Experimental: Part 2b
Cy-only LD
干预措施: Cyclophosphamide (Drug)
Experimental: Run-in
干预措施: ADI-001 (Drug)
结局指标
主要结局
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
时间窗: 28 days
This primary endpoint will be used to evaluate safety and tolerability of AD1-001 in subjects with treatment-refractory RA
次要结局
未报告次要终点