Recruiting
Phase 1
Phase 2

ECT204

Sponsor:

Eureka Therapeutics Inc.

Code:

NCT04864054

Conditions

Hepatocellular Carcinoma

Liver Cancer, Adult

Liver Neoplasm

Metastatic Liver Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ECT204 T cells

Study Details

Brief 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.

Conditions

Hepatocellular Carcinoma

Liver Cancer, Adult

Liver Neoplasm

Metastatic Liver Cancer

Study ID

NCT04864054

Start date

Mar 11, 2022

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm)

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.

Interventions

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 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 ]

Central Contacts and Locations

Central contacts

Teresa Klask, MBA

925-949-9314Teresa.Klask@eurekainc.com

Pei Wang, PhD

510-654-7045Pei.Wang@eurekainc.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Kimberley Le, RN, MSN

626-218-2997kimle@coh.org

Principal Investigator:

Daneng Li, MD

Montefiore Einstein Comprehensive Cancer Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Molly McHugh

718-920-7426momchugh@montefiore.org

Principal Investigator:

R. Alejandro Sica, MD

Oregon Health and Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Fatema Fareh

503-418-0345farehf@ohsu.edu

Principal Investigator:

Richard Maziarz, MD

University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Amala Poulose

Amala.Poulose@UTSouthwestern.edu

Principal Investigator:

David Hsieh, MD

Fred Hutchinson Cancer Center, University of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

Shelby Colden

206-667-5134scolden2@fredhutch.org

Principal Investigator:

William Harris, MD

More Information

Sponsor

Eureka Therapeutics Inc.

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Hepatocellular Carcinoma
  • Advanced HCC
  • Late-Stage HCC
  • Liver Cancer
  • Liver Neoplasm
  • Metastatic Liver Cancer
  • Metastatic HCC
  • T-cell therapy
  • Immunotherapy
  • HCC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eureka Therapeutics Inc. on 2026-06-09.