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Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors
Sponsor: Grit Biotechnology
Summary
This study is a multi-center, single-arm phase I clinical trial. A total of 26\~42 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study. An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period
Official title: A Multi-center,Single-arm Phase I/II Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2022-09-14
Completion Date
2025-05-01
Last Updated
2025-02-17
Healthy Volunteers
No
Conditions
Interventions
GT201
Autologous tumor infiltrating lymphocyte injection
Locations (4)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China