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)
Eureka Therapeutics Inc.
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.
Description
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-…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 b…
Interventions
- BiologicalECT204 T cells
ECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.
Locations (7)
- City of HopeDuarte, California
- Kansas University Medical Center, Principal Investigator:Westwood, Kansas
- Roswell Park Comprehensive Cancer CenterBuffalo, New York
- Oregon Health and Sciences UniversityPortland, Oregon
- University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer CenterDallas, Texas
- Fred Hutchinson Cancer Center, University of WashingtonSeattle, Washington