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

This is an open-label, dose-escalation, multi-center, Phase I/II clinical trial. The purpose of this study is to evaluate an investigational ECT204 T-cell therapy in adult patients with GPC3-positive advanced hepatocellular carcinoma (HCC). ECT204 is an autologous T-cell product built on the ARTEMIS® cell receptor platform that involves two GPC3-targeting surface components: an antibody-T-cell receptor (AbTCR) and a chimeric stimulating receptor (CSR; also referred to as the co-stimulatory molecule). In this study, T cells are collected from each patient and genetically modified ex vivo to co-express the GPC3-specific AbTCR and GPC3-specific CSR, then re-administered to the patient to selectively recognize and eliminate GPC3-expressing HCC tumor cells.

The protocol describes two parts: Part 1 (dose escalation) and Part 2 (expansion).

Part 1: Dose Escalation

Part 2: Expansion

\- The initial cohort of Part 2 is defined as the "RP2D Confirmatory Cohort"

'Phase 1' is defined as Part 1 plus the initial RP2D confirmatory cohort in Part 2, and 'Phase 2' is defined as the subsequent expansion cohort in Part 2.

The protocol itself does not label phases; it uses Part 1 and Part 2 terminology only.

The active assessment period of the study will continue for 2 years. Subjects will be followed for assessment of treatment safety and overall survival during Long Term Follow-Up (LTFU; year 2 -15).