A Clinical Study on TIL for the Treatment of Advanced Solid Tumors

Exclusion Criteria

• •1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
• •2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
• •3. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
• •4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
• •5. Severe physical or mental diseases;
• •6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
• •7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
• •8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
• •9. Having received immunotherapy and developed irAE level greater than Level 3;
• •10. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
• •11. Females in pregnancy or lactation;
• •12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
• •13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.