ACT#001 CAR-T Cells Injected Locally for Castration-Resistant Prostate Cancer
Tests ACT#001 CAR-T cells injected into the prostate in castration-resistant prostate cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
Where in China
- The First Affiliated Hospital of Zhejiang UniversityHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT07240857
- Record updated
- 22 May 2026
- Original description
An exploratory clinical study evaluating the safety and efficacy of ACT#001 chimeric antigen receptor T-cell (CAR-T cell) local injection in the treatment of castration-resistant prostate cancer.Read full original descriptionShow less
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
An exploratory clinical study evaluating the safety and efficacy of ACT#001 chimeric antigen receptor T-cell (CAR-T cell) local injection in the treatment of castration-resistant prostate cancer.
Inclusion: 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.
Exclusion: 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; 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; Presence of brain metastasis; Uncontrolled large-volume serous cavity effusions；.