Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Adverse Events (AE)
研究概览
简要总结
Multicenter, single arm, non-randomized, prospective, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (BEN101) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent and/or metastatic solid tumor.
详细描述
BEN101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with recurrent and/or metastatic solid tumor. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by 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
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BEN101
BEN101 infusion single dose level between 1x10^9 to 1x 10^11，not lower than 1×10^9 cells, final dose is affected by the starting amount of TILs cells isolated from the tumor tissue sample.
干预措施: BEN101 (Biological)
结局指标
主要结局
Adverse Events (AE)
时间窗: 6 month
Adverse events according to CTCAE v5.0, Treatment Emergent Adverse event (TEAE) \>=grade 3; Treatment related adverse event (TRAE).
次要结局
- Disease Control Rate (DCR）(Up to 24 months)
- Overall survival (OS)(Up to 24 months)
- Progression free survival (PFS)(Up to 24 months)
- Objective Response Rate (ORR)(Up to 24 months)
- Duration of response (DOR)(Up to 24 months)
研究者
Hongxia Wang
Director of Oncology Department
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine