This is a single-center, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Autologous tumor infiltrating lymphocyte injection
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Incidence and severity of adverse events per CTCAE 5.0
To characterize the safety profile of autologous TIL injection (GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adverse events per CTCAE 5.0
Time frame: From TIL infusion to the 24th week
Objective response rate (ORR)
To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 and iRECIST as assessed by the investigator.
Time frame: Up to 24 months post infusion
Disease control rate (DCR)
To evaluate the percentage of participants that achieved partial response (PR), complete response (CR), or stable disease (SD) after treatment among total number of evaluable patients.
Time frame: Up to 24 months post infusion
Progression-free survival (PFS)
To evaluate the time from the date of TIL infusion until disease progression per RECIST v1.1 and iRECIST as assessed by the investigator or death due to any cause.
Time frame: Up to 24 months post infusion
Duration of Response (DoR)
To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 and iRECIST as assessed by the investigator until disease progression or death due to any cause.
Time frame: Up to 24 months post infusion
Overall survival (OS)
To evaluate the time from the date of TIL infusion to death due to any cause.
Time frame: From the date of TIL infusion to date of death due to any cause, or up to 24 months post infusion (whichever occurs first)
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