T-Cell Therapy (ECT204) in Adults With Advanced HCC — ARYA-3  

Hepatocellular Carcinoma Clinical Trial

Official title: 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)

Status Recruiting

Clinical Trial 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.

Phase I has concluded and a Recommended Phase II Dose (RP2D) has been determined. We are now conducting Phase II to further confirm the safety profile of ECT204 and evaluate its efficacy.

Clinical Trial 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 ARTEMIS® ECT204 T-cell therapy in adult patients with GPC3-positive advanced hepatocellular carcinoma (HCC). In this study, a patient's T cells are collected and genetically modified to express Eureka's proprietary anti-GPC3 ARTEMIS T cell receptors (AbTCR). These modified T cells are then reintroduced into the patient to specifically seek out and destroy GPC3-expressing cancer cells.

Phase 1 (Dose Escalation Phase): Completed; RP2D of ECT204 was determined.

Phase 2 (Expansion Phase): The expansion phase includes 2 study arms.

Arm A: Subjects will receive ECT204 as monotherapy

Arm B: Subjects will receive pre-treatment with regorafenib (STIVARGA®) before ECT204 administration.

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). ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer, Adult
• Liver Neoplasm
• Liver Neoplasms
• Metastatic Liver Cancer

• NCT number: NCT04864054
• Study type: Interventional
• Source: Eureka Therapeutics Inc.
• Contact: Teresa Klask, MBA
• Phone: 925-949-9314
• Email: Teresa.Klask@eurekainc.com
• Status: Recruiting
• Phase: Phase 2
• Start date: March 11, 2022
• Completion date: December 31, 2026