Hepatocellular CarcinomaPhase 1/2ARYA-3NCT04864054
GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC
A Phase 1/2 study testing ECT204 T cells in people with Hepatocellular Carcinoma and Liver Cancer, Adult, run by Eureka Therapeutics Inc. at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer, Adult, Liver Neoplasm
- What is being tested?
- ECT204 T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 11 Mar 2022to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States7 sites, 5 recruiting
- Completed
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
- Recruiting
University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, 75235
Amala Poulose, Amala.Poulose@UTSouthwestern.edu
David Hsieh, MD
- Recruiting
City of Hope
Duarte, California, 91010
Kimberley Le, RN, MSN, 626-218-2997, kimle@coh.org
Daneng Li, MD
- Recruiting
Oregon Health and Sciences University
Portland, Oregon, 97239
Knight Cancer Institute, 503-494-1080, trials@ohsu.edu
Richard Maziarz, MD
- Recruiting
Fred Hutchinson Cancer Center, University of Washington
Seattle, Washington, 98109
Shelby Colden, 206-667-5134, scolden2@fredhutch.org
William Harris, MD
- Recruiting
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10467
Molly McHugh, 718-920-7426, momchugh@montefiore.org
R. Alejandro Sica, MD
- Completed
Kansas University Medical Center, Principal Investigator:
Westwood, Kansas, 66205
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Cancer Center
Taipei, 106
Guanlieng Chen, guanlieng.chen@doint.com.tw
Chiun Hsu, MD, PhD
About this study
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)
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.
Read the detailed description
ECT204 is an autologous T-cell product built on the ARTEMIS® Cell Receptor platform, incorporating two GPC3-targeting surface components: an antibody-T-cell receptor (AbTCR) and a chimeric stimulating receptor (CSR). Each subject's T cells are collected and genetically modified ex vivo to co-express these receptors, then re-administered to selectively recognize and eliminate GPC3-expressing HCC tumor cells.
The study consists of a completed Phase 1 and a Phase 2 expansion cohort. Phase 1 used a traditional 3+3 dose-escalation design to determine the recommended Phase 2 dose (RP2D), followed by an RP2D confirmatory cohort to further characterize safety. Phase 2 evaluates a multi-infusion strategy of up to four ECT204 infusions administered across two treatment cycles, with the second cycle administered to subjects who achieve stable disease or better at the Month 2 assessment.
The active assessment period extends for 2 years (24 months) after the first ECT204 infusion (Day 0). Subjects then enter long-term follow-up (LTFU) for ongoing safety and overall survival assessments through Year 15.
- Being tested
- ECT204 T cells
- Keywords
- Hepatocellular Carcinoma, Advanced HCC, Late-Stage HCC, Liver Cancer, Liver Neoplasm, Metastatic Liver Cancer, Metastatic HCC, T-cell therapy, Immunotherapy, HCC
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECT204 T cellsBiological
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 group | Role | What they receive |
|---|---|---|
| Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm) | Experimental | Dose Escalation Cohort: Participants receive a single infusion of ECT204 at one of four predefined dose levels on Day 0 (completed).
RP2D Confirmatory Cohort: Participants receive ECT204 at the RP2D on Day 0 and may receive a second infusion approximately one month later.
Expansion Cohort: Participants receive multiple infusions of ECT204 at the RP2D, beginning on Day 0, with subsequent infusions administered according to the protocol-defined schedule. Receives: Biological: ECT204 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of ECT204.
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.
Measured: Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years
Secondary outcomes (11)
To assess the efficacy of ECT204 using RECIST v1.1 | Overall Response Rate (ORR)
ORR, defined as the proportion of subjects with a best overall response (BOR) of either CR or PR.
Measured: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Duration of Response (DOR)
DOR, defined as the time from first documented occurrence of CR or PR to PD or death from any cause, whichever occurs first.
Measured: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Progression-Free Survival (PFS)
PFS, defined as the time from first ECT204 infusion to PD or death from any cause, whichever occurs first.
Measured: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Disease Control Rate (DCR)
DCR, defined as the proportion of subjects with BOR of CR, PR, or SD.
Measured: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Time to Response (TTR)
TTR, defined as the time from first ECT204 infusion to the first documented occurrence of CR or PR, among subjects who achieve an objective response.
Measured: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Time to Progression (TTP)
TTP, defined as the time from first ECT204 infusion to PD.
Measured: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Overall Survival (OS)
OS, defined as the time from first ECT204 infusion to death from any cause.
Measured: Up to 15 years
To evaluate changes in serum GPC3 as a pharmacodynamic marker of ECT204 activity.
Change from baseline in serum GPC3 over time; association between dynamic changes in serum GPC3 and radiographic tumor response by RECIST v1.1.
Measured: Up to 2 years
To characterize the pharmacokinetic (PK) profile of ECT204, including the expansion and persistence of ECT204 | Peak exposure (Cmax)
Cmax will be determined
Measured: Up to 2 years
To characterize the pharmacokinetic (PK) profile of ECT204, including the expansion and persistence of ECT204 | Time to reach peak exposure (Tmax)
Tmax will be determined
Measured: Up to 2 years
To characterize the pharmacokinetic (PK) profile of ECT204, including the expansion and persistence of ECT204 | Area under the concentration-time curve to the last quantifiable concentration (AUCt)
AUCt will be determined
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start11 Mar 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eureka Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pei Wang, PhD, Study director, Eureka Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864054
- Sponsor's protocol ID
- ETUS20GPC3AR124
- Acronym
- ARYA-3
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04864054
- Acronym / sponsor ID
- ARYA-3 / ETUS20GPC3AR124
- Keywords
- Hepatocellular Carcinoma, Advanced HCC, Late-Stage HCC, Liver Cancer, Liver Neoplasm, Metastatic Liver Cancer, Metastatic HCC, T-cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eureka Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ECT204 is an autologous T-cell product built on the ARTEMIS® Cell Receptor platform, incorporating two GPC3-targeting surface components: an antibody-T-cell receptor (AbTCR) and a chimeric stimulating receptor (CSR). Each subject's T cells are collected and genetically modified ex vivo to co-express these receptors, then re-administered to selectively recognize and eliminate GPC3-expressing HCC tumor cells.
The study consists of a completed Phase 1 and a Phase 2 expansion cohort. Phase 1 used a traditional 3+3 dose-escalation design to determine the recommended Phase 2 dose (RP2D), followed by an RP2D confirmatory cohort to further characterize safety. Phase 2 evaluates a multi-infusion strategy of up to four ECT204 infusions administered across two treatment cycles, with the second cycle administered to subjects who achieve stable disease or better at the Month 2 assessment.
The active assessment period extends for 2 years (24 months) after the first ECT204 infusion (Day 0). Subjects then enter long-term follow-up (LTFU) for ongoing safety and overall survival assessments through Year 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm) | Experimental | Biological: ECT204 T cellsDose Escalation Cohort: Participants receive a single infusion of ECT204 at one of four predefined dose levels on Day 0 (completed). RP2D Confirmatory Cohort: Participants receive ECT204 at the RP2D on Day 0 and may receive a second infusion approximately one month later. Expansion Cohort: Participants receive multiple infusions of ECT204 at the RP2D, beginning on Day 0, with subsequent infusions administered according to the protocol-defined schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed HCC, that is unresectable, recurrent, and/or metastatic.
- GPC3-positive tumor expression confirmed by immunohistochemistry (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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECT204 T cellsECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene. | Biological | Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm) |
Primary outcome
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.
11 secondary outcomes
To assess the efficacy of ECT204 using RECIST v1.1 | Overall Response Rate (ORR)
Time frame: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Duration of Response (DOR)
Time frame: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Progression-Free Survival (PFS)
Time frame: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Disease Control Rate (DCR)
Time frame: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Time to Response (TTR)
Time frame: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Time to Progression (TTP)
Time frame: Up to 15 years
To assess the efficacy of ECT204 using RECIST v1.1 | Overall Survival (OS)
Time frame: Up to 15 years
To evaluate changes in serum GPC3 as a pharmacodynamic marker of ECT204 activity.
Time frame: Up to 2 years
To characterize the pharmacokinetic (PK) profile of ECT204, including the expansion and persistence of ECT204 | Peak exposure (Cmax)
Time frame: Up to 2 years
To characterize the pharmacokinetic (PK) profile of ECT204, including the expansion and persistence of ECT204 | Time to reach peak exposure (Tmax)
Time frame: Up to 2 years
To characterize the pharmacokinetic (PK) profile of ECT204, including the expansion and persistence of ECT204 | Area under the concentration-time curve to the last quantifiable concentration (AUCt)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pei Wang, PhD study director
Eureka Therapeutics Inc.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ECT204 T cells in people with Hepatocellular Carcinoma and Liver Cancer, Adult, run by Eureka Therapeutics Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Klask, MBA (925-949-9314, Teresa.Klask@eurekainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.