NCT04864054

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Eureka Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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-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).

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	ECT204 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.

Timeline

• Start date: 2022-03-11
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-04-28
• Last updated: 2025-12-05

Locations

7 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study