NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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: 1. Absolute neutrophil count (ANC) ≥ 1.5× 109/L (±20%)； 2. Platelet (PLT） ≥ 75× 109/L (±20%）； 3. Hemoglobin (HGB) ≥ 90 g/L (±20%). * Liver and kidney function are normal: 1. Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥