This study is to investigate the safety and efficacy of signal switch receptor modified TIL (GC201 TIL) in patients with advanced gynecologic tumors. Autologous TILs from tumor resections or biopsies are first gene modified(TGF-β receptor or PD-1 gene modified TILs which could transfer the suppression signal surrounding the microenvironment of tumor bed into persistent T cell activation signal) and than expanded before i.v. infusion into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Age: 18 years to 75 years;
Histologically diagnosed as primary/relapsed/metastasized Gynecological tumors;
Expected life-span more than 3 months;
Karnofsky≥60% or ECOG score 0-2;
Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
Single group
Signal Switch Receptor Modified TIL
Biological/VaccineAdoptive transfer of 2x10\^8-1x10\^10 autologous signal switch receptor modified TILs to patients i.v. in 30-120 minutes.
Adverse Events (AE)
To characterize the safety profile of Signal Switch Receptor Modified TIL (GC201 TIL) in patients with advanced gynecologic tumors as assessed by incidence of adverse events related to GC201 TIL infusion.
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 TIL infusion，PET/CT scan will be performed at 6 weeks after GC201 TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)
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.
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
Change in Quality of Life
Comparison of patients' quality of life before and after GC201 TIL treatment as assessed by the EORTC QLQ-30 (V3.0).
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Shanghai Juncell Therapeutics
Lead sponsor
Shanghai 10th People's Hospital
Collaborator
