T-Cell Therapy (ECT204) for Adults with Advanced Liver Cancer (HCC)

Sponsor: Eureka Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04864054

Provider View

This clinical trial is testing a new T-cell therapy called ECT204 for adults with advanced liver cancer that is GPC3-positive. The study aims to determine if this treatment is safe and effective for patients who have not responded to or tolerated other treatments.

Patient Parameters

Program Overview

This study is exploring a new T-cell therapy, ECT204, for adults with advanced liver cancer (HCC) that shows a specific marker called GPC3. The trial is open to adults aged 18 and older who have not responded to or tolerated at least two different liver cancer treatments. The study is currently in Phase II, where researchers are confirming the safety and effectiveness of ECT204. In this treatment, a patient's T cells are collected, modified to target cancer cells, and then reintroduced to the patient to attack the cancer.

Description

This clinical trial is testing a new treatment called ECT204 T-cell therapy for adults with advanced liver cancer (HCC) that is GPC3-positive. The study is divided into two phases. Phase I has been completed, and researchers have determined the best dose for Phase II, which is now underway.

In this study, a patient's T cells are collected and genetically modified to target and destroy cancer cells that express the GPC3 marker. The modified T cells are then given back to the patient. The trial includes two groups:

  • Group A: Patients receive ECT204 as the only treatment.
  • Group B: Patients receive a medication called regorafenib (STIVARGA®) before getting ECT204.

The study will actively monitor patients for two years to assess the treatment's safety and effectiveness. After that, patients will be followed for up to 15 years to check on their long-term health and survival.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with liver cancer (HCC) that cannot be removed by surgery, has come back, or has spread.
  • Cancer cells must show a high level of GPC3 marker.
  • Must have tried at least two different liver cancer treatments without success.
  • Expected to live at least four more months.
  • Have a good overall health score (Karnofsky Performance Scale of 70 or higher).
  • Have measurable cancer that can be tracked.
  • Have a Child-Pugh score of A6 or better, indicating good liver function.
  • Have adequate organ function.

Exclusion Criteria

  • Have a serious illness that would prevent participation in the study.
  • Have an active, uncontrolled infection. Patients with HIV, hepatitis B, or hepatitis C can participate if their infection is controlled.
  • Have another active cancer, except for certain types that are not expected to spread or cause death within three years.
  • Have recently received or are currently receiving liver-directed treatments or surgery.
  • Are taking other experimental treatments or therapies.
  • Have an active autoimmune disease that requires treatment.
  • Have blocked blood flow in major liver veins.
  • Have had an organ transplant.
  • Have advanced liver cancer affecting more than half of the liver.

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