A Clinical Study of Genetically Modified TILs (GC203) for the Treatment of Pancreatic Ductal Adenocarcinoma

Introduction

GC203 TIL is a world-first genetically modified TIL therapy independently developed by Juncell Therapeutics. This study aims to evaluate the safety and efficacy of GC203 TIL in patients with pancreatic ductal adenocarcinoma who have failed standard therapy. The research is conducted in the Department of Pancreatic Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. The study has been approved by the hospital ethics committee and is now recruiting eligible patients.

Main Inclusion Criteria for subjects

1. 18-75 years.

2. Confirmed diagnosis of pancreatic ductal adenocarcinoma by cytology or histopathology.

3. Willing to undergo surgical resection of pancreatic cancer tissue for the preparation of genetically modified GC203 TIL cells, to be infused after failure to standard therapy.

4. Expected survival > 3 months prior to cell infusion.

5. ECOG score of 0–1 prior to cell infusion.

6. At least one evaluable tumor lesion before conditioning treatment (per RECIST 1.1 criteria).

7. Adequate hematologic and end-organ function.

8. Voluntary participation and signed the informed consent form.

Key exclusion criteria for subjects

Patients with other malignant tumors, severe cardiovascular disease, liver disease, renal disease, autoimmune disease, pulmonary disease, uncontrolled diabetes mellitus, psychiatric disorders, or infection with human immunodeficiency virus (HIV) or syphilis.