OncoMatch/Clinical Trials/NCT04864054
GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC
Is NCT04864054 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies ECT204 T cells for hepatocellular carcinoma.
Treatment: ECT204 T cells — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: GPC3 expression (IHC positive (dose escalation: ≥10-20% tumor cells, ≥2+ IHC; RP2D: ≥50% tumor cells, 2+/3+ IHC))
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — HCC
Must have received at least first-line systemic therapy for HCC and have experienced disease progression on, or intolerance to, that therapy.
Cannot have received: gene therapy (CAR-T cell therapy)
Exception: prior oncolytic virus therapy is permitted
Previously received other gene therapy (e.g., chimeric antigen receptor T-cell [CAR-T] therapy); exception: prior oncolytic virus therapy is permitted.
Lab requirements
Liver function
Child-Pugh score of A6 or better.
Child-Pugh score of A6 or better. Adequate organ function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Kansas University Medical Center, Principal Investigator: · Westwood, Kansas
- Roswell Park Comprehensive Cancer Center · Buffalo, New York
- Montefiore Einstein Comprehensive Cancer Center · The Bronx, New York
- Oregon Health and Sciences University · Portland, Oregon
- University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04864054 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene therapy disqualifies patients from enrollment.
Does this trial require GPC3?
Yes, GPC3 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages