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A clinical study of TILs expressing membrane-bound cytokines for the treatment of advanced gynecologic tumors

Tenth People's Hospital of Tongji University

Project

A clinical study of TILs expressing membrane-bound cytokines for the treatment of advanced gynecologic tumors

Introduction

As the world's first genetically modified TIL therapy based by non-viral vectors, GC203 gets safer and more affordable. This is an IIT clinical trial conducted in the Department of Obstetrics and Gynecology of Tenth People's Hospital of Tongji University for the treatment of advanced gynecologic tumors. Clinical patients are recruited in the project approved by the Ethics Committee of the hospital.

Main inclusion criteria for subjects

1. 18-75 years;

2. Expected survival > 3 months, Karnofsky ≥ 60% or with a ECOG score of 0-2;

3. Suffering from malignant gynecologic tumors diagnosed by Histopathology or Cytology; relapsed or metastased advanced tumors by imaging or pathology;failed or no standard treatment available;

4. Tumors suitable for surgical or puncture for the separation and culture of TILs;

5. One evaluable tumor lesion at least.

Main exclusion criteria for subjects

1. Suffering from severe organic or psychiatric illness;

2. Suffering from infectious diseases, such as tuberculosis, HIV, syphilis, hepatitis A, hepatitis B, hepatitis C, etc;

3. Suffering from diseases rely on corticosteroids or other immunosuppressive drugs.

Note: Only the main inclusion and exclusion criteria are listed above, the eligibility of individual subjects is to be judged by the physician after thorough evaluation according to the clinical trial.