This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A tumor sample is resected from each participant and cultured ex vivo to expand the population of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL.
Sichuan Cancer Hospital & Institute, Sichuan Cancer Center
Chengdu, China
Adverse Events
To characterize the safety profile of GC101 TIL in patients with pancreatic ductal adenocarcinoma 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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