Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Taiwan / NCT04864054
Recruiting Phase 1/2

GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC

NCT04864054 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Eureka Therapeutics Inc
Phase
Phase 1/2
Started
2022-03-11
Last updated
2026-09-10

Condition(s) studied

Hepatocellular CarcinomaLiver Cancer, AdultLiver NeoplasmMetastatic Liver Cancer

Investigational drug(s) / intervention(s)

ECT204 T cells

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.

Study summary

This is an open-label, multi-center, Phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of ECT204, an investigational ARTEMIS® T-cell therapy, in adult subjects with GPC3-positive hepatocellular carcinoma (HCC) who have experienced disease progression on, or intolerance to, prior systemic therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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 received at least first-line systemic therapy for HCC and have experienced disease progression on, or intolerance to, that therapy. * Life expectancy of at least 4 months per the Investigator's opinion. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * 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 controlled. * History of malignancy other than HCC within 5 years before screening, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancies with low risk of recurrence. * Known brain metastases or other active central nervous system (CNS) involvement, including leptomeningeal disease. Subjects with brain metastases that have been adequately treated (no evident neurological deficit and no steroid or anti-epileptic therapy for brain metastases) are eligible. * Pregnant or lactating women. * Currently receiving or ending (\< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery. * Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study. * Active autoimmune disease requiring systemic immunosuppressive therapy. * Presence of portal vein tumor thrombus (PVTT) classified as grade Vp4, or any invasion into the inferior vena cava (IVC), except for subjects with IVC invasion who have been treated and radiographically stable for at least 6 months prior to screening. * Ascites requiring active treatment, such as a requirement for paracentesis or escalation of diuretic doses. Exception: Subjects maintained on a stable dose of diuretics with controlled, asymptomatic ascites are eligible. * Active gastrointestinal (GI) bleeding event ≥ Grade 3 per National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), version 5.0, within 6 months prior to screening. * Coagulation abnormality defined as international normalized ratio (INR) \> 1.7, unless the elevation is due to therapeutic anticoagulation that, in the Investigator's judgment, can be safely managed in the context of study procedures. * History of organ transplant. * HCC involving greater than 50% of the liver volume. * Experienced allergies to any component of the study drug (ECT204), mouse immunoglobulin, or iron-dextran, or have a history of severe hypersensitivity, including anaphylaxis. * Previously received other gene therapy (e.g., chimeric antigen receptor T-cell \[CAR-T\] therapy); exception: prior oncolytic virus therapy is permitted.). * Contraindication for undergoing leukapheresis procedure or receipt of conditioning agents

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
Kansas University Medical Center, Principal Investigator: Westwood Kansas Completed
Roswell Park Comprehensive Cancer Center Buffalo New York Completed
Montefiore Einstein Comprehensive Cancer Center The Bronx New York Recruiting
Oregon Health and Sciences University Portland Oregon Recruiting
University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center Dallas Texas Recruiting
Fred Hutchinson Cancer Center, University of Washington Seattle Washington Recruiting
National Taiwan University Cancer Center Taipei Taiwan Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04864054 on ClinicalTrials.gov ↗ ← All trials in Taiwan