Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 9
- 主要终点
- Phase II part
研究概览
简要总结
Phase I Part :
Confirm the safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer, and decide recommended dose for Phase II.
Phase II Part :
Explore the efficacy and safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer at the recommended dose of GAIA-102 decided in the Phase I part.
详细描述
Phase I Part :
The GAIA-102 cohort (Level A1~A3) and the GAIA-102 + Pembrolizumab cohort (Level B1~B3) will be implemented in a 3 + 3 design. First, start from Level A1 and set the DLT evaluation period until Day 28 of Cycle 1, and confirm the safety up to Cycle 1_Day 28 of Level A1. After that, Level A2 and Level B1 will be started in parallel. After that, unless MTD is recognized, the safety at each level will be confirmed in sequence, and the recommended doses of Phase II part will be determined.
Phase II Part :
At the recommended number of doses confirmed in Phase I Part, 20 patients will be administered up to 3 cycles, and the safety and efficacy of GAIA-102 alone or with pembrolizumab will be evaluated by ORR.
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
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been confirmed to have NSCLC by histological or cytological examination
- •Patients with ECOG performance status (PS) 0-1 at the time of obtaining consent
- •Patients aged 20 years or older at the time of obtaining consent
排除标准
- •Patients with symptomatological cranial nerve system metastasis. If treatment for cranial nerve system metastasis has already been performed and the neurologically recovered state has been maintained for 2 weeks or more before registration, registration is possible.
- •Patients diagnosed with cancerous meningitis
- •Patients who received allogeneic hematopoietic stem cell transplantation
- •Patients with active autoimmune disease
研究组 & 干预措施
GAIA-102 alone
GAIA-102: 1 vial (2 x 10^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks.
干预措施: Biological (Biological)
GAIA-102 with Pembrolizumab
GAIA-102: 1 vial (2 x 10^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks.
Pembrolizumab：200 mg Administer on Day 1.
干预措施: Biological (Biological)
结局指标
主要结局
Phase II part
时间窗: Week 26
Objective Response Rate (%)
Phase I part
时间窗: Cycle 1 (Cycle period is 28 days)
Dose Limiting Toxicity
次要结局
- Phase I part(2 year)
- Phase II part(2 year)