Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination With Other Agents, in Participants With Advanced Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Adaptimmune
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants Enrolled Across Sub Studies
研究概览
简要总结
This trial will evaluate the safety and efficacy of first time in human engineered T-cell therapies, in participants with advanced tumors.
详细描述
This study is a master protocol. It has two sub studies registered as 209012 Sub Study 1 (NCT06048705) and 209012 Sub Study 2 (NCT05943990).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This will be an open-label study. Hence, there will be no masking
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy.
干预措施: GSK3901961 (Drug)
Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy.
干预措施: Cyclophosphamide (Drug)
Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy.
干预措施: Fludarabine (Drug)
Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy.
干预措施: GSK3901961 (Drug)
Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy.
干预措施: Cyclophosphamide (Drug)
Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy.
干预措施: Fludarabine (Drug)
Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy.
干预措施: GSK3845097 (Drug)
Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy.
干预措施: Cyclophosphamide (Drug)
Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy.
干预措施: Fludarabine (Drug)
Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy.
干预措施: GSK4427296 (Drug)
Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy.
干预措施: Cyclophosphamide (Drug)
Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy.
干预措施: Fludarabine (Drug)
结局指标
主要结局
Number of Participants Enrolled Across Sub Studies
时间窗: Day -7
Number of Participants Randomized across sub studies are presented.
次要结局
未报告次要终点