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ACT#001-PSMA CAR-T is an investigational, autologous chimeric antigen receptor (CAR) T-cell therapy designed to target Prostate-Specific Membrane Antigen (PSMA) for the treatment of castration-resistant prostate cancer (CRPC). Developed by Orig Stone Biotech in collaboration with Zhejiang University, the therapy utilizes a unique dual-regulation system known as FB-PSMA. CAR expression is initially triggered by localized thermal induction (43°C) at the tumor site, which activates a heat-sensitive promoter. Once the CAR molecules are expressed and bind to PSMA on tumor cells, a positive feedback mechanism further upregulates CAR expression to enhance localized cytotoxic activity. This localized activation and antigen-dependent feedback loop are intended to minimize systemic 'on-target, off-tumor' toxicities, which can be fatal in solid tumor treatments. The therapy is typically administered via transrectal ultrasound-guided local injection directly into the prostate or localized lesions.
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