GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC

ECT204 is an autologous T-cell product built on the ARTEMIS® Cell Receptor platform, incorporating two GPC3-targeting surface components: an antibody-T-cell receptor (AbTCR) and a chimeric stimulating receptor (CSR). Each subject's T cells are collected and genetically modified ex vivo to co-express these receptors, then re-administered to selectively recognize and eliminate GPC3-expressing HCC tumor cells. The study consists of a completed Phase 1 and a Phase 2 expansion cohort. Phase 1 used a traditional 3+3 dose-escalation design to determine the recommended Phase 2 dose (RP2D), followed by an RP2D confirmatory cohort to further characterize safety. Phase 2 evaluates a multi-infusion strategy of up to four ECT204 infusions administered across two treatment cycles, with the second cycle administered to subjects who achieve stable disease or better at the Month 2 assessment. The active assessment period extends for 2 years (24 months) after the first ECT204 infusion (Day 0). Subjects then enter long-term follow-up (LTFU) for ongoing safety and overall survival assessments through Year 15.