This study is to investigate the safety and efficacy on TIL engineered with membrane-binding cytokine (GC203 TIL) for the treatment of patients with advanced gynecologic tumors. Autologous TILs from tumor resections or biopsies are first gene modified (engineered with membrane-binding cytokine) and than expanded before i.v. infusion into the patient after NMA lymphodepletion treatment with cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Adoptive transfer of 2x10\^8-1x10\^10 autologous TIL engineered with membrane-binding cytokine to patients i.v. in 30-120 minutes.
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Adverse Events (AE)
To characterize the safety profile of TIL engineered with membrane-binding cytokine (GC203 TIL) in patients with advanced gynecologic tumors as assessed by incidence of adverse events related to GC203 TIL infusion.
Time frame: Up to 6 months
Objective Response Rate (ORR)
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD. ( Except baseline evaluation within 28 days before GC203 TIL infusion,PET/CT scan will be performed at 6 weeks after GC203 TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)
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 v1.1: DCR (proportion of patients) = # with CR + # with PR + # with SD / # with CR + # with PR + # with SD + # with PD.
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 GC203 TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
Time frame: Up to 36 months
Overall Survival (OS)
The length of time from the date of the start of GC203 TIL treatment that the patients are still alive
Time frame: Up to 36 months
Change in Quality of Life
Comparison of patients' quality of life before and after GC203 TIL treatment as assessed by the EORTC(The European Organization for Reasearch and Treatment of Cancer) QLQ-30(Quality of Life Questionnare-Core30 ) (V3.0). The outcome will be calculated by software from different dimensions.
Time frame: Up to 36 months
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