A Single-arm, Open-label, Dose-finding Clinical Study of TCR-T Cells in Patients With HLA-A2-expressing and NY-ESO-1-positive Recurrent or Metastatic Solid Tumors

Fujian Cancer Hospital0 个研究点目标入组 30 人开始时间: 2022年12月最近更新: 2022年12月13日

适应症

干预措施

试验速览

阶段: 早期 1 期
状态: 尚未招募
发起方: Fujian Cancer Hospital
入组人数: 30
主要终点: Dose Limiting Toxicity

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging life.

详细描述

This is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.

TCR-T cells are expanded from peripheral blood, and after ex vivo modification, 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 TCR-T cells in patients with recurrent/metastatic solid tumors.

The second purpose of this study is to preliminarily explore the effectiveness of TCR-T cells 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: Sequential
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

•Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
•18 ~70 years old (gender is not limited;)
•The expected survival period is at least 3 months;
•ECOG score of 0-1;
•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;
•According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;
•NY-ESO-1 positive;
•HLA type is HLA-A2 (except HLA-A*0203);

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.