This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
A tumor sample is resected from each participant and cultured ex vivo to expand the population of engineered tumor infiltrating lymphocytes injection (GC203 TIL). After lymphodepletion, patients are infused GC203 TIL.
Adverse Events
To characterize the safety profile of GC203 TIL in patients with Solid Tumors who were failed to standard treatment as assessed by incidence of adverse events.
Time frame: 6 month
Objective Response Rate (ORR)
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 36 months
Disease Control Rate (DCR)
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to 36 months
Duration of Response (DOR)
The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
Time frame: Up to 36 months
Progression-Free Survival (PFS)
The time from TIL infusion until disease progression or death from any cause.
Time frame: Up to 36 months
Overall Survival(OS)
The time from TIL infusion until death from any cause.
Time frame: Up to 36 months
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