Phase I Trial of A-CAR032, a CAR-T Cell Therapy for Adult Men with Metastatic Castration-Resistant Prostate Cancer Who Have Had Prior ARPI Treatment

What this Trial Is About

Researchers are evaluating A-CAR032, a new CAR-T cell therapy, in adults with metastatic castration-resistant prostate cancer mCRPC who have previously progressed after androgen receptor pathway inhibitor ARPI treatment and are not eligible for standard treatment. This Phase I trial is the first time this treatment is being tested in humans and aims to assess its safety, antitumor activity, pharmacodynamics, biomarkers, immunogenicity, and feasibility. The study has two parts Part 1 involves dose escalation to find the maximum tolerated or recommended dose, using three planned dose levels with 3 to 9 participants each. Part 2 involves dose expansion at the recommended dose to further evaluate safety and biological activity with about 12 participants. The treatment includes screening, apheresis collection of cells, possible bridging therapy, lymphodepletion, and a single intravenous infusion of the CAR-T cells, followed by detailed follow-up in several stages. Participants will undergo multiple assessments including safety monitoring from consent until up to 15 years after infusion, evaluations of efficacy and pharmacokinetics up to 12 months or longer, and collection of tumor material for biomarker analysis. Safety reviews occur throughout the first 28 days post-infusion and over extended periods. The trial includes long-term follow-up to monitor outcomes and potential effects of the therapy, lasting up to 15 years after treatment.

A Phase I Trial of A-CAR032 in Participants With mCRPC