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;
Shanghai Juncell Therapeutics
Lead sponsor
Shanghai 10th People's Hospital
Collaborator