NCT04864054 · Eureka Therapeutics Inc.
T-Cell Therapy (ECT204) in Adults With Advanced HCC
(ARYA-3)
What this study is about
This is an where both patients and doctors know the treatment given, gradually increasing doses, multi-center, Phase I/II clinical trial aimed at assessing the safety and preliminary effectiveness of an experimental ARTEMIS® ECT204 T-cell therapy.
View original scientific description
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.
Interventions
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.
Primary outcome measures
To assess the safety and tolerability of ECT204.
Time frame: Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years
Type, frequency, and severity of adverse events (AEs), including treatment-emergent AEs (TEAEs), treatment-related AEs (TRAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), clinically significant laboratory abnormalities recorded as AEs, and AEs leading to permanent discontinuation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically confirmed HCC, which is unresectable, recurrent and/or metastatic.
- GPC3-positive expression in HCC tumor cells confirmed by immunohistochemistry (IHC).
- For Phase 1 (dose escalation): ≥10-20% tumor cells, ≥2+ IHC).
- For Phase 2 (expansion): ≥ 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. Previously treated lesions are allowed as long as there is a new confirmed measurable component.
- 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
Where
- Duarte, California
- Westwood, Kansas
- Buffalo, New York
- The Bronx, New York
- Portland, Oregon
- Dallas, Texas
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 9, 2026 · Source of record for eligibility and locations