T-Cell Therapy (ECT204) in Adults With Advanced HCC
Trial Parameters
Brief Summary
This is an open-label, dose escalation, multi-center, Phase I/II clinical trial aimed at assessing the safety and preliminary efficacy of an investigational ARTEMIS® ECT204 T-cell therapy. The trial is suitable for adult subjects (≥ 18 years of age) diagnosed with GPC3-positive HCC, who have failed or not tolerated at least two (2) different anti-HCC systemic agents.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed HCC, that is unresectable, recurrent, and/or metastatic. * GPC3-positive tumor expression confirmed by immunohistochemistry (IHC). * For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC. * Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+/3+ IHC. * Must have failed, or not tolerated, at least two (2) different anti-HCC systemic agents. * Life expectancy of at least 4 months per the Investigator's opinion. * Karnofsky Performance Scale of 70 or higher. * Measurable disease by RECIST v1.1. * Child-Pugh score of A6 or better. * Adequate organ function. Exclusion Criteria: * Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements. * Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is contr