A Clinical Study Evaluating the Safety and Efficacy of Local Injection of ACT#001 Chimeric Antigen Receptor T Cells in the Treatment of Castration-Resistant Prostate Cancer

Prior treatment

• Organ transplantation or pending organ transplantation;
• A history of receiving other cell therapies or genetically modified cell therapies (e.g., TCR-T therapy, CAR-T therapy);
• A history of receiving any PSMA-targeted therapy;
• Requirement for steroid therapy (except for physiological replacement therapy);
• A history of receiving immunotherapies;

Other illness

• A history of autoimmune diseases；
• A history of clinically significant central nervous system (CNS) diseases (either past or present at screening);
  • (12) A history of other untreated malignant tumors; (13) Participants with severe cardiovascular diseases; (14) Active infectious diseases; (15) Active hepatitis B or hepatitis C virus infection; (16) Active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection (17) Intolerance or allergy to cyclophosphamide or fludarabine chemotherapeutic drugs; (18) No accessible injection sites; (19) Assessment by the investigator that the participant is unsuitable for participation in this clinical study.

Other

• Presence of brain metastasis;
• Uncontrolled large-volume serous cavity effusions；

• understanding of this study and voluntarily signs the informed consent form;
• Aged ≥ 18 years;
• Expected survival time of at least 3 months;
• non-metastatic CRPC (nmCRPC) (local recurrence) or metastatic CRPC (mCRPC)；
• continue GnRH analog therapy；
• at least one evaluable lesion per RECIST 1.1;
• Has received at least one type of novel endocrine therapy；
• PSMA positive expression rate \> 10%;
• Eastern Cooperative Oncology Group (ECOG) 0-1;
• Well organ function
• Left Ventricular Ejection Fraction (LVEF) \> 50%;
• Oxygen saturation \> 92% without oxygen supplementation;
• agree to use effective contraceptive measures