A Single-center, Open-label Clinical Study of TIL Cells for the Treatment of the Recurrent/Metastatic Solid Tumors Patients Who Had Failed Standard Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TILs) therapy in patients with Advanced malignant solid tumors. TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.
详细描述
This is a single-center, open-label, Phase I clinical study of TILs for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.
TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.
The primary purpose of this study is to evaluate the safety and tolerability of TILs in patients with recurrent/metastatic solid tumors.
The second purpose of this study is to preliminarily explore the effectiveness of TILs in patients with recurrent/metastatic solid tumors.
Eligibility:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
- •18 ~ 75 years;
- •The expected survival period is at least 3 months;
- •ECOG score of 0-1;
- •There is at least one lesion that can be operated or biopsied for the preparation of TIL;
- •According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;
- •Patients with recurrent or metastatic solid tumors confirmed by histopathology;
- •Subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression
排除标准
- •Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline ;
- •Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;
- •Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time;
- •Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma;
- •Patients who have received adoptive cell therapy in the past;
- •According to the judgment of the investigator, the condition of the subject is not suitable for this trial.
研究组 & 干预措施
Tumor Infiltrating Lymphocytes
TIL cells (2.5×10^9-5×10^10) will be infused i.v. to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.
干预措施: Tumor Infiltrating Lymphocytes (Biological)
Tumor Infiltrating Lymphocytes
TIL cells (2.5×10^9-5×10^10) will be infused i.v. to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.
干预措施: Fludarabine (Drug)
Tumor Infiltrating Lymphocytes
TIL cells (2.5×10^9-5×10^10) will be infused i.v. to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.
干预措施: Cyclophosphamide Capsules (Drug)
Tumor Infiltrating Lymphocytes
TIL cells (2.5×10^9-5×10^10) will be infused i.v. to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.
干预措施: IL-2 (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: up to Day 28
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TILs therapy.
Adverse Event
时间窗: up to 24 months
The severity and incidence of various adverse events and serious adverse events
次要结局
- Progression free survival (PFS)(up to 24 months)
- Overall survival (OS)(up to 24 months)
- Overall response rate(ORR)(up to 24 months)