An Open,Single-center,Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- MDT
研究概览
简要总结
A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection.
To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others.
详细描述
This is an open, single-center Phase I clinical trial designed to assess the safety, tolerability, efficacy, and feasibility of tumor-associated lymph node T cells (TAL-T) for treating metastatic solid tumors. The study consists of three distinct phases: screening, administration of treatment, and follow-up evaluation. In this investigation, TAL-T cells will be cultured after being separated in a laboratory setting. Participants will receive 1-2 infusions of TAL-T cells.
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 75 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
Cohort A
Three patients were planned to be enrolled, and each subject received one to two cell transfusions.
干预措施: Tumor Associated Lymph node T cell (Drug)
Cohort A
Three patients were planned to be enrolled, and each subject received one to two cell transfusions.
干预措施: cyclophosphamide (Drug)
Cohort A
Three patients were planned to be enrolled, and each subject received one to two cell transfusions.
干预措施: IL-2 (Drug)
Cohort B
14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection.
干预措施: Tumor Associated Lymph node T cell (Drug)
Cohort B
14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection.
干预措施: cyclophosphamide (Drug)
Cohort B
14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection.
干预措施: IL-2 (Drug)
Cohort B
14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection.
干预措施: Serplulimab Injection (Drug)
结局指标
主要结局
MDT
时间窗: At least 58 days
Determine the maximum tolerated dose of TAL-T
DLT
时间窗: At least 58 days
The dosage of TAL-T was determined to limit toxicity
Number of participants with treatment-related adverse events as assessed by CTCAE V4.03
时间窗: At least 60 days
Keep record the adverse eventd experienced by subjects in 30 days after the last infusion
次要结局
- life quality score(At least 70 days)
- ORR(one yaer)
- PFS(two years)