A Phase I clinical trial of the autologous natural TIL (GC101) for the treatment of advanced malignant solid tumors

Clinical Trials

Chinese PLA General Hospital

Introduction

GC101 is the first autologous natural TIL injection developed by Juncell Therapeutics (Acceptance no.: CXSL2200070). As the first TIL therapy which only needs low-intensity pre-treatment and no IL-2 injection in the world, GC101 has been validated for its clinical efficacy and safety which greatly improves the safety and accessibility of TIL therapy.

Clinical patients are currently recruited by Chinese PLA General Hospital for an open-label, single-arm, Phase I clinical trial of GC101 TIL in patients with advanced malignant solid tumors.

Main inclusion criteria for subjects

1. 18 - 75 years, male or female;

2. Diagnosed malignant solid tumors, including melanoma, non-small cell lung cancer, cervical cancer, head and neck squamous cell carcinoma, endometrial cancer, liver cancer, gastric cancer, colorectal cancer, esophageal squamous cell carcinoma, bile duct carcinoma, renal cancer, nasopharyngeal carcinoma, ovarian cancer, triple-negative breast cancer, thymic cancer, neuroendocrine tumor, etc;

3. Failed in standard treatment, or not applicable to the current standard regimen , or lack of effective treatment methods (unlimited to the number of treatment lines);

4. 2 lesions at least; able to undergo the surgery to collect tumor tissue;

5. With a ECOG score of 0-1, underlying diseases (hypertension, heart disease, diabetes, etc.) are under good control;;

6. Sign the informed consent form (ICF) voluntarily and is able to comply with the protocol-specified visits and related procedures;

7. Agree to receive no other anti-tumor therapies during this study.

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.