T-Cell Therapy for Advanced Liver Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of an investigational T-cell therapy, ECT204, in adults with advanced hepatocellular carcinoma (HCC) that expresses GPC3. The study involves collecting and genetically modifying patients' T cells to target and destroy cancer cells expressing GPC3. It consists of a Phase I component that has concluded and a Phase II expansion phase with two arms: one receiving ECT204 alone and the other receiving regorafenib prior to ECT204. Participants will be monitored for safety and overall survival over a period of up to 15 years.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Montefiore Einstein Comprehensive Cancer Center
  The Bronx, New York, United States Recruiting
• Oregon Health and Sciences University
  Portland, Oregon, United States Recruiting
• University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center
  Dallas, Texas, United States Recruiting
• Fred Hutchinson Cancer Center, University of Washington
  Seattle, Washington, United States Recruiting
• National Taiwan University Cancer Center
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Teresa Klask, MBA
• Email: Teresa.Klask@eurekainc.com
• Phone: 925-949-9314

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.