A Phase I clinical trial of the autologous genetically modified TIL (GC203) for the treatment of advanced malignant solid tumors（KunLun-001）

Fudan University Shanghai Cancer Center, Tianjin Medical University Cancer Institute & Hospital, Tenth People’s hospital of Tongji University, The Second Affiliated Hospital Zhejiang University School of Medicine, etc.

Introduction

GC203 TIL-ST-I (KunLun-001) is a open-label, single-arm phase 1 clinical trial, aimed to investigate the safety and efficacy of GC203 in the advanced malignant solid tumor patients.

Main inclusion criteria for subjects

1. 18 - 75 years, male or female;

2. Diagnosed malignant solid tumors, including cervical cancer, endometrial cancer, breast cancer, digestive cancer, non-small cell lung cancer, 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. Brain metastasis leading to organic mental disorders;

4. Received genetically engineered cell therapies within one year.

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.