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Clinical Trials in China / NCT07240857
Enrolling by invitation Early Phase 1

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

NCT07240857 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Early Phase 1
Started
2026-04-12
Last updated
2026-05-22

Condition(s) studied

Castration-Resistant Prostate Cancer (CRPC)

Investigational drug(s) / intervention(s)

Intraprostatic or localized lesion injection of ACT#001-PSMA CAR-T cells under transrectal ultrasound (TRUS) guidance

Intraprostatic or localized lesion injection of ACT#001-PSMA CAR-T cells under transrectal ultrasound (TRUS) guidance: Prior to CAR-T cell infusion, subjects will receive lymphodepleting chemotherapy based on fludarabine and cyclophosphamide. Surgical method : 1)The patient is taken to the operating room, and the anesthesia method is intravenous anesthesia or local anesthesia. A digital rectal examination is performed, and the anus is dilated to accommodate three fingers. The genitals and perineum are prepared and covered in a sterile manner. An ultrasound probe is inserted into the rectum; (2) Under ultrasound guidance, CAR-T cells are injected into the prostate or localized lesions via the rectum or perineum; (3) Then, the TRUS probe is removed from the patient's rectum.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria 1. understanding of this study and voluntarily signs the informed consent form; 2. Aged ≥ 18 years; 3. Expected survival time of at least 3 months; 4. non-metastatic CRPC (nmCRPC) (local recurrence) or metastatic CRPC (mCRPC)； 5. continue GnRH analog therapy； 6. at least one evaluable lesion per RECIST 1.1; 7. Has received at least one type of novel endocrine therapy； 8. PSMA positive expression rate \> 10%; 9. Eastern Cooperative Oncology Group (ECOG) 0-1; 10. Well organ function 11. Left Ventricular Ejection Fraction (LVEF) \> 50%; 12. Oxygen saturation \> 92% without oxygen supplementation; 13. agree to use effective contraceptive measures Exclusion Criteria 1. Presence of brain metastasis; 2. Organ transplantation or pending organ transplantation; 3. Uncontrolled large-volume serous cavity effusions； 4. A history of autoimmune diseases； 5. A history of receiving other cell therapies or genetically modified cell therapies (e.g., TCR-T therapy, CAR-T therapy); 6. A history of receiving any PSMA-targeted therapy; 7. Requirement for steroid therapy (except for physiological replacement therapy); 8. A history of receiving immunotherapies; 9. 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.

Primary outcome measure(s)

  • DLT — 28 days
    adverse events occurring within 28 days after the first infusion that are related to the study drug (definitely related, probably related, possibly related).

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang

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Other trials for the same condition

YS247 (Neoantigen-Pulsed DC Vaccine) for Metastatic Prostate Cancer Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07240857 on ClinicalTrials.gov ↗ ← All trials in China