Not Yet RecruitingEarly 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

18 participantsStarted 2025-12-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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%;

Exclusion criteria

✕. Presence of brain metastasis;
✕. Organ transplantation or pending organ transplantation;
✕. Uncontrolled large-volume serous cavity effusions；
✕. A history of autoimmune diseases；
✕. 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;

What they're measuring

DLT

Timeframe: 28 days

Trial details

NCT IDNCT07240857

SponsorZhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

Weijia Fang, MD

86-0571-87237587 weijiafang@zju.edu.cn

View on ClinicalTrials.gov More Castration-Resistant Prostate Cancer (CRPC) trials