20 Participants Needed

ECT204 T-Cell Therapy for Liver Cancer

(ARYA-3 Trial)

Recruiting at 5 trial locations
KB
PW
TK
TK
TK
Overseen ByTeresa Klask, MBA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ECT204 T-cell therapy for liver cancer, specifically targeting GPC3-positive HCC. Researchers aim to assess the safety of this treatment and its potential to combat cancer when other treatments have failed. The trial consists of two parts: determining the optimal dose and then testing its effectiveness. Suitable candidates are adults with inoperable liver cancer, specific tumor markers, and a history of unsuccessful treatment with at least two other cancer therapies. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the ECT204 T-Cell Therapy trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents or liver tumor-directed therapies while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ECT204 T-cell therapy is still under investigation, but some findings about its safety have emerged. T-cell therapy uses a person's own modified immune cells to combat cancer, and this treatment has shown promise in targeting liver cancer cells.

In earlier studies, some patients experienced partial remissions, where their cancer reduced in size, while others maintained stable disease for over three years, meaning their cancer did not progress. This suggests the treatment can be effective without severe side effects for some individuals.

However, this remains an investigational treatment in the middle stages of testing, requiring further research to fully understand its safety. Participants in the study are closely monitored for any side effects, and researchers adjust doses to determine the safest amount.

For those considering joining this trial, it is important to remember that the treatment is experimental, but there is growing evidence that it can be well-tolerated by some patients. Always discuss any concerns or questions with a doctor to understand the possible risks and benefits.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about ECT204 T-cell therapy for liver cancer because it harnesses the power of modified T cells to specifically target and attack cancer cells. Unlike traditional treatments like surgery, chemotherapy, and targeted therapies such as sorafenib, which can affect both healthy and cancerous tissues, ECT204 offers a precision approach with the potential for fewer side effects. Additionally, in one treatment arm, regorafenib is used as a pre-treatment to potentially enhance the T-cell therapy's effectiveness, offering a novel combination strategy that could improve outcomes for patients.

What evidence suggests that this trial's treatments could be effective for liver cancer?

Studies have shown that ECT204 T-cell therapy targets a protein called GPC3, often found in large amounts on liver cancer cells, particularly in hepatocellular carcinoma (HCC). Research indicates that these specially designed T-cells can effectively identify and attack these cancer cells. In early studies, ECT204 demonstrated strong activity against tumors with GPC3. Initial findings suggest that this therapy could help shrink tumors or slow their growth in patients with advanced liver cancer.

In this trial, participants will join different treatment arms. One arm will receive ECT204 T-cell therapy as monotherapy, while another will receive ECT204 T-cell therapy following pre-treatment with regorafenib. This approach represents a promising new way to treat liver cancer by harnessing the body's immune system.12346

Who Is on the Research Team?

PW

Pei Wang, PhD

Principal Investigator

Eureka Therapeutics Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Life expectancy of at least 4 months per Principal Investigator's opinion
My liver cancer cells test positive for GPC3.
I am able to care for myself but may not be able to do active work.
See 5 more

Exclusion Criteria

My liver cancer affects more than half of my liver.
I have a serious health condition like heart failure.
I am currently undergoing or have recently finished (within 14 days) a treatment specifically targeting liver tumors.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 (Dose Escalation)

Completed; RP2D of ECT204 was determined

21 months

Phase 2 (Expansion)

Subjects receive ECT204 as monotherapy or with pre-treatment regorafenib

2 years

Long Term Follow-Up

Subjects are followed for assessment of treatment safety and overall survival

13 years

What Are the Treatments Tested in This Trial?

Interventions

  • ECT204 T cells
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Regorafenib Pre-Treatment + ECT204 ArmExperimental Treatment2 Interventions
Group II: ECT204 Monotherapy ArmExperimental Treatment1 Intervention

ECT204 T cells is already approved in United States for the following indications:

🇺🇸
Approved in United States as ECT204 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eureka Therapeutics Inc.

Lead Sponsor

Trials
12
Recruited
160+

Published Research Related to This Trial

The CT017 CAR T cell therapy, targeting the GPC3 antigen in patients with advanced hepatocellular carcinoma (HCC), demonstrated a manageable safety profile, with all patients experiencing cytokine release syndrome (CRS) that resolved after treatment, but no cases of neurotoxicity were observed.
Among the six heavily pretreated patients, there was a 16.7% objective response rate and a 50% disease control rate, indicating promising antitumor activity, with a median overall survival of 7.9 months, suggesting potential efficacy that warrants further investigation in larger trials.
RUNX-3-expressing CAR T cells targeting glypican-3 in patients with heavily pretreated advanced hepatocellular carcinoma: a phase I trial.Fu, Q., Zheng, Y., Fang, W., et al.[2023]
The fourth-generation GPC3-targeted CAR-T cells (GPC3-BBZ-7×19) demonstrated enhanced proliferation and chemotactic abilities compared to second-generation CAR-T cells, indicating a potentially more effective treatment for hepatocellular carcinoma (HCC).
In vivo studies showed that GPC3-BBZ-7×19 CAR-T cells significantly eliminated GPC3-positive HCC tumors in immunodeficient mice, suggesting they could provide a durable and effective therapeutic option for HCC in future clinical trials.
[Construction and function of Glypican-3-targeted fourth-generation chimeric antigen receptor T cells (secreting IL-7 and CCL19)].Huang, W., Liu, Y., Hu, Y., et al.[2020]
In two phase I studies involving 13 patients with advanced GPC3+ hepatocellular carcinoma, CAR-GPC3 T-cell therapy showed an initial safety profile, with manageable side effects like fever and cytokine release syndrome, and no severe neurotoxicity reported.
The therapy demonstrated early signs of antitumor activity, with overall survival rates of 50.3% at 6 months and 42.0% at 1 year, along with two partial responses observed, suggesting potential efficacy in treating this type of cancer.
Chimeric Antigen Receptor-Glypican-3 T-Cell Therapy for Advanced Hepatocellular Carcinoma: Results of Phase I Trials.Shi, D., Shi, Y., Kaseb, AO., et al.[2021]

Citations

T-Cell Therapy (ECT204) in Adults With Advanced HCCThe purpose of this study is to evaluate an investigational ARTEMIS® ECT204 T-cell therapy in adult patients with GPC3-positive advanced hepatocellular ...
Eureka Therapeutics Tackling Advanced Hepatocellular ...Eureka Therapeutics' ECT204, an investigational autologous glypican 3 (GPC3)-directed T-cell therapy based on the company's ARTEMIS platform ...
Targeting Glypican-3 for Liver Cancer TherapyPreclinical and clinical evidence indicates that CAR-T cells engineered to target GPC3 exhibit potent cytotoxic activity against GPC3-positive ...
ECT204 T-Cell Therapy for Liver Cancer (ARYA-3 Trial)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 ...
Phase II Progress for Eureka's GPC3-Targeted T-Cell ...The trial is assessing the efficacy of the company's ECT204 T-cell therapy in treating hepatocellular carcinoma (HCC), a liver cancer that is ...
Clinical Trial: NCT04864054The purpose of this study is to investigate an autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ECT204 T cells are ...
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