Phase I Study of CART-PSMA Cells in Patients With Advanced Prostate Cancer
This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer.
• All participants must have the ability to understand and the willingness to sign a written informed consent.
• Histologic confirmation of prostate cancer.
• Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
• Under general air conditions, blood oxygen saturation \>90%.
• Adequate liver function, specifically alanine aminotransferase (ALT) \< 3 times of upper limit of normal (ULN), aspartate transferase (AST)\< 3 times of ULN, serum bilirubin and alkaline phosphatase \< 2 times of ULN.
• Adequate renal function, specifically serum creatinine \< 2.0 mg/dl.
• Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.
• Hemoglobin concentration ≥80g/L.
⁃ The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy.