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

NCT04864054 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ETUS20GPC3AR124
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Hepatocellular Carcinoma; Liver Cancer, Adult; Liver Neoplasm; Metastatic Liver Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Assess the safety and tolerability of ECT204 in adult subjects with advanced HCC

  Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities

  Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years

• Determine the Recommended Phase II Dose (RP2D) of ECT204 (Concluded During Phase 1 of the study)

  RP2D determination is based on the maximum tolerated dose (MTD), defined as the highest dose level at which the proportion of subjects experiencing a Dose-Limiting Toxicity (DLT) is less than or equal to 30% and does not exceed the maximum administered dose (MAD). Final determination is based on the observed DLT rates and manufacturing capability, and is made by the Dose Escalation Committee (DEC).

  Up to 28 days

Secondary Outcomes (10)

• Assess the efficacy of ECT204 in adult subjects with advanced HCC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (RECIST v1.1) as the primary criterion.

  Up to 2 years

• Assess the efficacy of ECT204 | Disease Control Rate

  Up to 2 years

• Assess the efficacy of ECT204 | Duration of Response

  Up to 15 years

• Assess the efficacy of ECT204 | Progression-Free Survival

  Up to 15 years

• Assess the efficacy of ECT204 | Time to Progression (TTP)

  Up to 15 years

Study Arms (1)

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

EXPERIMENTAL

Dose Escalation Cohort: Patients receive a single infusion of ECT204 T cells at one of four predefined dose levels on Day 0 after conditioning. Conditioning consists of fludarabine (Flu) and cyclophosphamide (Cy). RP2D Confirmatory Cohort: Patients receive ECT204 T cells at the RP2D on Day 0 and may receive a second infusion approximately one month later. This cohort uses the same Flu/Cy conditioning as the dose-escalation cohort; no conditioning is given before the second ECT204 infusion. Expansion Cohort: Patients receive multiple ECT204 infusions at the RP2D (initial on Day 0, planned second on Day 31, and optional third or later doses). The third infusion may be administered no earlier than Day 60, and each subsequent infusion must be separated by at least 30 days. Patients receive Flu/Cy/regorafenib before the first infusion and regorafenib alone before the second and subsequent infusions.

Biological: ECT204 T cells

Interventions

ECT204 T cells BIOLOGICAL

ECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 failed, or not tolerated, at least two (2) different anti-HCC systemic agents.
• Life expectancy of at least 4 months per the Investigator's opinion.
• Karnofsky Performance Scale of 70 or higher.
• Measurable disease by RECIST v1.1.
• Child-Pugh score of A6 or better.
• Adequate organ function.

You may not qualify if:

• 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.
• Active malignancy (other than HCC), with the exception of cholangiocarcinoma (CCA) or any malignancy without any organ involvement and with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen- deprivation therapy).
• 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).
• Ascites requiring active treatment.
• History of organ transplant.
• Advanced HCC involving greater than half (50%) of the liver.

Sponsors & Collaborators

• Eureka Therapeutics Inc.: lead

Study Sites (7)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Kansas University Medical Center, Principal Investigator:

Westwood, Kansas, 66205, United States

COMPLETED

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

RECRUITING

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

Dallas, Texas, 75235, United States

RECRUITING

Fred Hutchinson Cancer Center, University of Washington

Seattle, Washington, 98109, United States

RECRUITING

National Taiwan University Cancer Center

Taipei, 106, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Pei Wang, PhD

  Eureka Therapeutics Inc.

  STUDY DIRECTOR

Central Study Contacts

Teresa Klask, MBA

CONTACT

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

Pei Wang, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 28, 2021
• Study Start: March 11, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

US (6); TW (1)