Autologous Tumor Infiltrating Lymphocyte (TIL) GT201 Infusion.

Inclusion criteria

Key eligibility criteria for inclusion in the study:

• 1 Age 18~70 years old;
• 2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available;
• 3 At least one lesion that is resectable for the preparation of autologous TIL cells;
• 4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling;
• 5 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• 6 Expected survival ≥ 12 weeks;
• 7 Non-surgically sterilized women of reproductive age who agree to use at least one medically recognized method of contraception during the study treatment period and for 1 year after the end of the study treatment period; and must have a negative serum test at screening, prior NMA-LD and cell infusion.

Exclusion criteria

Subjects will be excluded from the study for one or more of the following conditions:

• 1 Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment);
• 2 Bleeding events within 3 months prior to screening
• 3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening
• 4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function;
• 5 Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association (NYHA) Class grade > grade 2;
• 6 Participants with ≥ 3 untreated central nervous system (CNS) metastases;
• 7 Have any historical or active autoimmune disease requiring systemic steroids, or immunosuppressive therapy (> 10 mg/day of prednisone or equivalent);
• 8 Malignant tumors other than the target indication within 5 years;
• 9 The presence of refractory or intractable epilepsy, large amounts of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by drugs, or other contraindications to IL-2 use;
• 10 Patients with infectious diseases, will be excluded from the study; with some exceptions for HBV and HCV.
• 11 Previous allogeneic bone marrow transplantation or solid organ transplantation;