Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04864054

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

Led by Eureka Therapeutics Inc. · Updated on 2025-12-05

20

Participants Needed

7

Research Sites

303 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed unresectable, recurrent, or metastatic hepatocellular carcinoma (HCC)
  • GPC3-positive tumor confirmed by immunohistochemistry (IHC): 10-20% tumor cells with 2+ IHC for dose escalation, 50% or more tumor cells with 2+/3+ IHC for expansion cohort
  • Have failed or not tolerated at least two different anti-HCC systemic agents
  • Life expectancy of at least 4 months according to investigator
  • Karnofsky Performance Scale score of 70 or higher
  • Measurable disease by RECIST v1.1 criteria
  • Child-Pugh score of A6 or better
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Pre-existing illnesses limiting study compliance, such as symptomatic congestive heart failure
  • Active, uncontrolled systemic bacterial, fungal, or viral infections
  • Active malignancy other than HCC, except cholangiocarcinoma or malignancies without organ involvement and expected survival of 3 years or more without treatment
  • Pregnant or lactating women
  • Receiving or ending liver tumor-directed therapy or hepatic surgery within 14 days before consent
  • Concurrent participation in other investigational treatment studies
  • Active autoimmune disease requiring systemic immunosuppressive therapy
  • Presence of portal vein tumor thrombus grade Vp4 or invasion into the inferior vena cava
  • Ascites requiring active treatment
  • History of organ transplant
  • Advanced HCC involving more than half of the liver

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

City of Hope

Duarte, California, United States, 91010

Actively Recruiting

2

Kansas University Medical Center, Principal Investigator:

Westwood, Kansas, United States, 66205

Completed

3

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14263

Actively Recruiting

4

Oregon Health and Sciences University

Portland, Oregon, United States, 97239

Actively Recruiting

5

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

Dallas, Texas, United States, 75235

Actively Recruiting

6

Fred Hutchinson Cancer Center, University of Washington

Seattle, Washington, United States, 98109

Actively Recruiting

7

National Taiwan University Cancer Center

Taipei, Taiwan, 106

Actively Recruiting

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Research Team

T

Teresa Klask, MBA

CONTACT

P

Pei Wang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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