An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours

Inclusion criteria

• AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment;
• The patient has residual lesions that can be used for surgical resection (>1.5cm3) or biopsy (>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation;
• Laboratory inspection index requirements:

• Blood routine: lymphocyte ratio > 20%; neutrophil count > 1.0 × 10^9/L; white blood cells > 3.0 × 10^9/L; platelets > 100 × 10^9/L; hemoglobin > 80 g/ L;
• Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (ALP) ≤ upper limit of normal x 2.5; total gallbladder Red pigment (TBIL)≤normal upper limit×1.5;
• Renal function: urea ≤ upper limit of normal × 1.5; creatinine (Cr) ≤ upper limit of normal × 1.5;
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• ECOG physical condition is 0 or 1;
• The expected survival time is more than 3 months;

Exclusion criteria

• Suffering from active or previous autoimmune diseases ;
• Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
• Combined with severe infection or persistent infection and cannot be effectively controlled;
• Central nervous system metastasis and/or cancerous meningitis;
• With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• Requires systemic steroid therapy;
• Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb); positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis;