A Phase I/II Clinical Study of TC-N201 Injection for the Treatment of Advanced Solid Tumors With HLA-A2 Expression and Positive NY-ESO-1.
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.
• Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial;
• Age ≥ 18 years and ≤ 70 years;
• Expected survival time \> 3 months;
• ECOG score 0-1;
• Metastatic or recurrent solid tumors confirmed by histopathology;
• Refractory to standard treatment evaluated by radiological assessment;
• Be able provide fresh or preserved tissue specimen;
• At least 1 measurable lesion (according to RECIST 1.1);
• NY-ESO-1 expression positive: Immunohistochemical staining positive cells ≥25% and positive staining intensity is ++ or above;
• HLA typing is HLA-A2 (excluding HLA-A\*0203);
• Hematology should at least meet the following criteria:
‣ Absolute neutrophil count (ANC) ≥ 1.5× 109/L (±20%)；
⁃ Platelet (PLT） ≥ 75× 109/L (±20%）；
⁃ Hemoglobin (HGB) ≥ 90 g/L (±20%).
• Liver and kidney function are normal:
‣ Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml/min;
⁃ Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤ 2.5 times of upper limit of normal;
⁃ Total bilirubin (TBIL) ≤ 15 times of upper limit of normal.
• Blood coagulation function is normal: Prothrombin time (PT) ≤ 1.5 ULN, International Normalized Ratio (INR) ≤ 1.5 ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN;
• Echocardiogram results show: Left ventricular ejection fraction \>45%;
• Women of childbearing potential should be ascetic or take contraception since the signing of ICF to 24 weeks or later after the last administration of drug Note: Women of childbearing age who have undergone surgical sterilization or who have already experienced menopause are considered to have no possibility of pregnancy.
• Before the TC-N201 injection was reconstituted, the toxic effects of standard treatment had already recovered, and the corresponding adverse events were judged by the researcher to not pose a safety risk;
• Catheter insertion is feasible and No White Blood Cells collection contraindications.