CART-PSMA Cells for 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.

Inclusion Criteria: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.Exclusion Criteria:Patients with other malignant tumors or major diseases.Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.Patients with uncontrolled active infection.Patients with active hepatitis B or hepatitis C infection.Patients with human immunodeficiency virus (HIV) infection.Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).Patients with various types of serious heart disease or a history of severe cerebrovascular disease.Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy.Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.