A Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma
98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial,this trail is expected to be finished in 24 months
• Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
• Aged ≥18 years and ≤75 years, regardless of gender;
• Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma) ;
• Patients who have failed or resisted to PD-1 antibodies;
• Patients must have failed or resisted to at least two frontlines systemic tehrapy(if knowed with BRAF V600 mutate, then need to failed to BRAF/MEK inhibitor; if knowed with NRAS mutate, then need to failed to Tunlametinib) ;
• TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;There are still at least 1 measurable lesion (according to RECIST1.1 criteria ) even after TIL sampling and resection of surgically resectable tissue;
• ECOG performance status 0-1;
• Expected survival time \>3 months;
• With sufficient hematology and end-organ function;
• Good compliance and able to adhere to the study visit plan and other agreement requirements.