Actively Recruiting
An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-3)
Led by Eureka Therapeutics Inc. · Updated on 2025-12-05
20
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational T-cell therapy called ECT204 for adults aged 18 years or older who have advanced hepatocellular carcinoma (HCC) that expresses the GPC3 protein. This open-label, multi-center Phase I/II trial focuses on patients whose cancer has not responded to or who have not tolerated at least two different anti-HCC treatments. The study aims to assess the safety and initial effectiveness of this therapy, which uses genetically modified T cells to target tumor cells. The trial has two parts: Part 1 is a dose escalation where patients receive a single infusion of ECT204 T cells after conditioning with fludarabine and cyclophosphamide. Part 2 includes an expansion phase with several cohorts, including a confirmatory cohort receiving one or two infusions and an expansion cohort receiving multiple infusions at the recommended dose. Some patients also receive regorafenib alongside conditioning or before subsequent infusions. Participants will be monitored over two years for safety and response, with long-term follow-up continuing up to 15 years to assess overall survival and treatment persistence. Assessments include imaging to measure tumor response using RECIST criteria, pharmacokinetic studies of the T-cell therapy, and evaluations of disease control and progression. The study involves regular clinical visits, laboratory tests, and ongoing safety evaluations throughout the follow-up period.
CONDITIONS
Brief Title
T-Cell Therapy (ECT204) in Adults With Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed hepatocellular carcinoma that is unresectable, recurrent, or metastatic
- Tumor tested positive for GPC3 by immunohistochemistry with required expression levels depending on the study cohort
- Failed or not tolerated at least two different systemic anti-HCC treatments
- Life expectancy of at least 4 months as judged by the investigator
- Karnofsky Performance Scale score of 70 or higher
- Measurable disease according to RECIST v1.1 criteria
- Child-Pugh score of A6 or better
- Adequate organ function as determined by study requirements
You will not qualify if you...
- Serious pre-existing illness that would affect compliance with the study
- Active, uncontrolled systemic bacterial, fungal, or viral infection; controlled HIV, hepatitis B, or hepatitis C allowed
- Active cancers other than HCC except cholangiocarcinoma or cancers without organ involvement and long expected survival
- Pregnant or breastfeeding women
- Recent liver tumor-directed therapy or hepatic surgery within 14 days before consent
- Receiving other investigational agents or therapies during the study
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Portal vein tumor thrombus grade Vp4 or invasion into inferior vena cava
- Ascites requiring active treatment
- History of organ transplant
- Advanced HCC involving more than half of the liver tissue
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years (active assessment period)
Participants receive conditioning chemotherapy followed by one or more infusions of the investigational ECT204 T-cell therapy. Initial treatment includes a single infusion after conditioning, with possible additional infusions depending on cohort assignment.
1 to multiple infusions over several months with visits on Day 0, Day 31, Day 60, and subsequent monthly visits as applicable
Duration - Up to 15 years
Participants are followed for long-term safety and overall survival assessments after treatment.
Periodic follow-up visits during years 2 to 15
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
Research Team
T
Teresa Klask, MBA
P
Pei Wang, PhD
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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