30 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

Trial Summary

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.

What data supports the effectiveness of the ECT204 T-cell therapy for liver cancer?

Research shows that T-cell therapies targeting glypican-3 (GPC3), a protein found in liver cancer cells, have shown promise in preclinical and early clinical trials. These therapies have demonstrated the ability to expand, persist, and effectively attack liver cancer cells in both laboratory and animal studies, suggesting potential effectiveness for treating liver cancer.12345

What safety data exists for ECT204 T-Cell Therapy for Liver Cancer?

Research on similar T-cell therapies targeting glypican-3 (GPC3) for liver cancer suggests that dual-targeting approaches may reduce the risk of harming healthy tissues while maintaining strong cancer-fighting abilities. However, specific safety data for ECT204 T-Cell Therapy in humans is not detailed in the available studies.23678

What makes ECT204 T-cell therapy unique for liver cancer treatment?

ECT204 T-cell therapy is unique because it targets glypican-3 (GPC3), a protein found on liver cancer cells, using engineered T cells that are designed to enhance their expansion and antitumor activity. This therapy is novel as it incorporates specific enhancements like the 4-1BB costimulatory domain, which improves T-cell proliferation and antitumor response, making it potentially more effective against solid tumors like liver cancer compared to traditional treatments.235910

What is the purpose of this 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 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.

Research Team

PW

Pei Wang, PhD

Principal Investigator

Eureka Therapeutics Inc.

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
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.

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

🇺🇸
Approved in United States as ECT204 for:
  • Hepatocellular carcinoma (HCC) - Orphan drug designation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eureka Therapeutics Inc.

Lead Sponsor

Trials
12
Recruited
160+

Findings from Research

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]
Transgenic expression of IL15 and IL21 in GPC3-CAR T cells significantly enhances their ability to proliferate and persist, leading to improved antitumor activity against hepatocellular carcinoma (HCC) in preclinical models.
The combination of IL15 and IL21 with a second-generation GPC3-CAR (GBBz) resulted in superior T cell expansion and a higher percentage of memory T cell populations, suggesting a promising approach for future clinical trials in HCC patients.
Glypican-3-Specific CAR T Cells Coexpressing IL15 and IL21 Have Superior Expansion and Antitumor Activity against Hepatocellular Carcinoma.Batra, SA., Rathi, P., Guo, L., et al.[2020]
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]

References

RUNX-3-expressing CAR T cells targeting glypican-3 in patients with heavily pretreated advanced hepatocellular carcinoma: a phase I trial. [2023]
Glypican-3-Specific CAR T Cells Coexpressing IL15 and IL21 Have Superior Expansion and Antitumor Activity against Hepatocellular Carcinoma. [2020]
[Construction and function of Glypican-3-targeted fourth-generation chimeric antigen receptor T cells (secreting IL-7 and CCL19)]. [2020]
Identification of glypican-3-derived long peptides activating both CD8+ and CD4+ T cells; prolonged overall survival in cancer patients with Th cell response. [2021]
Chimeric Antigen Receptor-Glypican-3 T-Cell Therapy for Advanced Hepatocellular Carcinoma: Results of Phase I Trials. [2021]
Development of T cells carrying two complementary chimeric antigen receptors against glypican-3 and asialoglycoprotein receptor 1 for the treatment of hepatocellular carcinoma. [2017]
Development of GPC3 and EGFR-dual-targeting chimeric antigen receptor-T cells for adoptive T cell therapy. [2021]
T Cells Engineered to Express a T-Cell Receptor Specific for Glypican-3 to Recognize and Kill Hepatoma Cells In Vitro and in Mice. [2022]
Redirecting T Cells to Glypican-3 with 4-1BB Zeta Chimeric Antigen Receptors Results in Th1 Polarization and Potent Antitumor Activity. [2022]
GPC3-targeted CAR-T cells secreting B7H3-targeted BiTE exhibit potent cytotoxicity activity against hepatocellular carcinoma cell in the in vitro assay. [2022]
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