Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma

Prior treatment

• Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;
• Have used any cell therapy products in recent 3 months;
• Live vaccine inoculation within 4 weeks before enrollment;
• Subjects have participated in any other clinical research within 3 months before joining this clinical research;

Other illness

• People who have a history of allergy to any component in cell products;
• Grade 3 hypertension and poor blood pressure control after drug treatment;
• Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;
• Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;
• There is uncontrolled active infection;
• HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers;
• Subjects have a history of alcohol abuse, drug abuse or mental illness;
• Female subjects have any of the following conditions: a) are in pregnancy/lactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;

Lab values

• The following conditions occur in blood routine examination: WBC ≤ 1 × 109/L, absolute value of neutrophil ANC ≤ 0.5 × 109/L, absolute value of lymphocyte ALC ≤ 0.5 × 109/L , PLT≦25 × 109/L ；
• The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg/dl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg/dl;
• According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)\<50% by echocardiography;

Other

• Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;
• The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study.

• Aged 18-70 (≥ 18, ≤ 70), regardless of gender;
• Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;
• Late recurrent or metastatic soft tissue sarcoma confirmed by histopathology; Progress after receiving first-line treatment;
• According to RECIST 1.1 standard, there are clear assessable lesions;
• The expression of NY-ESO-1 in tumor tissue was confirmed by immunohistochemical staining; HLA-A configuration is 02/01;
• Within 2 weeks before cell therapy, no antibody drugs were used;
• ECOG score is 0-2;
• The subject has no contraindication for peripheral blood collection;
• The expected survival period is more than 3 months.