A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 57
- 主要终点
- Disease Assessment for Objective Response Rate
研究概览
简要总结
Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen.
详细描述
Lifileucel is an autologous adoptive cell transfer therapy that utilizes a TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with metastatic melanoma. The adoptive cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preconditioning regimen, prior to infusion of autologous TIL, followed by the administration of a regimen of IL-2.
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
- 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
Cohort 2
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
干预措施: Lifileucel (Biological)
Cohort 3
Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b).
干预措施: Lifileucel (Biological)
Cohort 4
Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
干预措施: Lifileucel (Biological)
Cohort 1
Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)
干预措施: Lifileucel (Biological)
结局指标
主要结局
Disease Assessment for Objective Response Rate
时间窗: Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months
Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for Cohorts 1 \& 3 and as assessed by Independent Review Committee (IRC) per RECIST Version 1.1 for Cohorts 2 \& 4
次要结局
- Disease Assessment for Duration of Response(Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months)
- Disease Assessment for Disease Control Rate(Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months)
- Disease Assessment for Progression-Free Survival(Every 6 weeks for 6 months, then every 3 months for a maximum of 60 months)
- Overall Survival(Until death or up to 60 months)