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 or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample
Third Affiliated Hospital of Naval Medical University
Shanghai, China
RECRUITINGAdverse Events
To characterize the safety profile of TILs in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events.
Time frame: 6 months
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)
Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1
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 length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
Time frame: Up to 36 months
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