A Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma（MIZAR-003）

Beijing Cancer Hospital, Fujian Cancer Hospital, Fudan University Shanghai Cancer Center, Zhejiang Cancer hospital, Hunan Cancer Hospital, Henan Cancer Hospital, Cancer Hospital of Shandong First Medical University, etc..

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.

This study (MIZAR-003) is to investigate the efficacy and safety of GC101 TIL therapy versus investigator's choice of chemotherapy in patients with advanced melanoma. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with cyclophosphamide and hydroxychloroquine.

Main inclusion criteria for subjects

1. Aged ≥18 years and ≤75 years, regardless of gender;

2. Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma) ;

3. Patients who have failed or resisted to PD-1 antibodies；

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

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;

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.