What side effects are associated with this type of intervention?

Common treatments for liver cancer, particularly those involving modified T-cell therapies like ARTEMIS® ECT204, include immune-based therapies and targeted therapies. Known side effects of these treatments can include infusion reactions, fatigue, fever, chills, and headache. More serious adverse events may include cytokine release syndrome, neurotoxicity, and potential liver toxicity. Close monitoring is essential to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including targeted therapies and immunotherapies. Sorafenib (Nexavar) was one of the first targeted therapies approved for advanced hepatocellular carcinoma (HCC). More recently, immune checkpoint inhibitors such as atezolizumab in combination with bevacizumab have shown efficacy in treating unresectable HCC. While specific T-cell therapies targeting GPC3-positive cancer cells like ARTEMIS® ECT204 are still under investigation, these approvals highlight the growing role of targeted and immune-based therapies in liver cancer treatment.

What other types of research exist?

Promising novel alternatives to ARTEMIS® ECT204 T-cell therapy for liver cancer patients include: 1) Durvalumab plus tremelimumab, which has shown improved survival outcomes in clinical trials. 2) Lenvatinib, a multi-kinase inhibitor, which has demonstrated efficacy as a first-line treatment. 3) Atezolizumab plus bevacizumab, which has shown significant improvement in overall survival and progression-free survival in advanced liver cancer. These therapies represent advanced options with robust clinical trial data supporting their use.

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CAR T-cell Therapy

ECT204 T-Cell Therapy for Liver Cancer (ARYA-3 Trial)

Phase 2

Recruiting

Research Sponsored by Eureka Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

GPC3-positive expression in HCC tumor cells by immunohistochemistry (IHC)

Karnofsky Performance Scale ≥ 70

Must not have

Advanced HCC involving greater than half (50%) of the liver

Clinically significant pre-existing illness (e.g., heart failure)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment where a patient's immune cells are modified to better fight liver cancer. It is for adults with a specific type of liver cancer who haven't had success with other treatments. The modified cells are designed to find and kill cancer cells with a particular marker.

Who is the study for?

Adults with advanced liver cancer (HCC) who have tried at least two treatments without success can join this trial. They should have a life expectancy of 4+ months, good organ function, and their cancer must show GPC3-positive expression. A score indicating mild liver disease (Child-Pugh A6 or better) and a performance status showing they're mostly independent are also required.

What is being tested?

The ECT204 T-cell therapy is being tested in adults with HCC that's not removable by surgery or has spread. This Phase I/II trial will determine the safest dose to use while checking how well it works against liver cancer.

What are the potential side effects?

While specific side effects for ECT204 T cells aren't listed here, similar therapies often cause immune reactions, fatigue, fever, and potential harm to healthy tissues due to an overactive immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver cancer cells test positive for GPC3.

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I am able to care for myself but may not be able to do active work.

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I have tried at least two treatments for liver cancer that didn't work or caused side effects.

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My liver cancer cannot be removed by surgery and has come back or spread.

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My liver functions well enough for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver cancer affects more than half of my liver.

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I have a serious health condition like heart failure.

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My blood flow in the liver or main veins is blocked.

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I do not have any ongoing serious infections.

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I am currently receiving treatment for an autoimmune disease.

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I have had an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess the safety and tolerability of ECT204 in adult subjects with advanced HCC

To determine the Recommended Phase II Dose (RP2D) of ECT204 (Concluded During Phase 1 of the study)

Secondary study objectives

To 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.

To characterize the pharmacokinetic (PK) profile of ECT204, including the expansion and persistence of ECT204, in our study subject population

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment2 Interventions

Approximately 10-15 subjects will receive ECT204 at the RP2D by intravenous infusion and preceded by cyclophosphamide and fludarabine chemotherapy for lymphodepletion. Arm B subjects will also receive pre-treatment with regorafenib (STIVARGA®) before ECT204 administration.

Group II: Arm AExperimental Treatment1 Intervention

Approximately 10-15 subjects will receive ECT204 at the RP2D by intravenous infusion and preceded by cyclophosphamide and fludarabine chemotherapy for lymphodepletion.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for liver cancer include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as tyrosine kinase inhibitors (e.g., sorafenib and lenvatinib), work by blocking specific molecules involved in tumor growth and angiogenesis. Immunotherapies, including immune checkpoint inhibitors (e.g., nivolumab), enhance the body's immune response against cancer cells. The ARTEMIS® ECT204 T-cell therapy, a form of modified T-cell therapy, targets GPC3-positive cancer cells by engineering T-cells to recognize and attack these specific tumor cells. This approach is significant for liver cancer patients as it offers a more personalized and potentially effective treatment option, especially for those who have not responded to conventional therapies.

Systemic Therapy for Hepatocellular Carcinoma: Chinese Consensus-Based Interdisciplinary Expert Statements.Combination approaches in hepatocellular carcinoma: How systemic treatment can benefit candidates to locoregional modalities.