Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC
Trial Parameters
Brief Summary
This is one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects.
Eligibility Criteria
Inclusion Criteria: 1. Fully understood and voluntarily signed informed consent for this study; 2. male, aged 18-75 years; 3. expected survival of more than 6 months; 4. metastatic castration-resistant prostate adenocarcinoma (CRPC) patients. 5. Receiving CRPC standard treatment (such as new endocrine therapy, chemotherapy and radium-223, etc., one or more of the combination therapy) after the diagnosis of CRPC, ineffective or progressive disease (PSA continued to rise for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastatic lesions, demonstrating disease progression); 6. PSMA expression in tumor cells was positive in immunohistochemical staining of prostate/metastatic biopsy tissue before enrollment; 7. ECOG score \< 2 ; 8. virological examination HAV (hepatitis A virus), HBV (hepatitis B virus), HCV (hepatitis C virus), HIV (human immunodeficiency virus), TP (Treponema pallidum) quantitative detection was negative, (antigen and antibody screening met