An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-3)
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.
• 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.