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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Autologous tumor infiltrating lymphocyte injection
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGIncidence and severity of adcersed events per CTCAE 5.0
To characterize the safety profile of autologous TIL injection(GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
Time frame: 3 years
Objective response rate
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
Time frame: 3 years
Progression-free survival
To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator
Time frame: 3 years
Overall survival
To evaluate efficacy parameters such Overall Survival (OS)
Time frame: 3 years
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