CART-PSMA Cells for Advanced Prostate Cancer

Inclusion Criteria:

1. All participants must have the ability to understand and the willingness to sign awritten informed consent.

2. Histologic confirmation of prostate cancer.

3. Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or othermethods.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

5. Under general air conditions, blood oxygen saturation >90%.

6. Adequate liver function, specifically alanine aminotransferase (ALT) < 3 times ofupper limit of normal (ULN), aspartate transferase (AST)< 3 times of ULN, serumbilirubin and alkaline phosphatase < 2 times of ULN.

7. Adequate renal function, specifically serum creatinine < 2.0 mg/dl.

8. Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.

9. Hemoglobin concentration ≥80g/L.

10. The side effects brought by the latest treatment should be recovered, and the latestchemotherapy should be at least 7 days before; At least three t½ have passed sincethe latest immunotherapy.

Exclusion Criteria:

1. Patients with other malignant tumors or major diseases.

2. Patients who are already undergoing other clinical drug trials or other gene therapyor cell therapy.

3. Patients with uncontrolled active infection.

4. Patients with active hepatitis B or hepatitis C infection.

5. Patients with human immunodeficiency virus (HIV) infection.

6. Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).

7. Patients with various types of serious heart disease or a history of severecerebrovascular disease.

8. Patients with congenital immune deficiency diseases or bone marrow deficiencydiseases.

9. 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 prolongedimmunosuppressive therapy.

10. Patients with active medical condition that, in the opinion of thephysician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.