Clinical Trials /

ECT204 T-Cell Therapy in Adults With Advanced HCC

NCT04864054

Description:

This will be an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of ECT204 T-cell therapy and determine the RP2D in adult subjects (≥ 18 years of age) who have GPC3-positive HCC and have failed or not tolerated at least two (2) different anti-HCC systemic agents.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04864054

Trial Eligibility

Document

Title

  • Brief Title: ECT204 T-Cell Therapy in Adults With Advanced HCC
  • Official Title: An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-3)

Clinical Trial IDs

  • ORG STUDY ID: ETUS20GPC3AR124
  • NCT ID: NCT04864054

Conditions

  • Hepatocellular Carcinoma
  • Liver Cancer, Adult
  • Liver Neoplasm
  • Metastatic Liver Cancer

Interventions

DrugSynonymsArms
ECT204 T cellsECT204

Purpose

This will be an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of ECT204 T-cell therapy and determine the RP2D in adult subjects (≥ 18 years of age) who have GPC3-positive HCC and have failed or not tolerated at least two (2) different anti-HCC systemic agents.

Detailed Description

      The purpose of this study is to investigate an autologous T-cell therapy for advanced
      hepatocellular carcinoma (HCC). ECT204 T cells are autologous T cells genetically modified to
      carry a construct capable of mediating cell killing by targeting tumor specific antigens.

Trial Arms

NameTypeDescriptionInterventions
ECT204ExperimentalA minimum of twelve (12) subjects will be treated to determine the RP2D.
  • ECT204 T cells

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed HCC, which is unresectable, recurrent and/or metastatic.

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

          -  Must have failed or not tolerated at least two (2) different anti-HCC systemic agents.

          -  Life expectancy of at least 4 months per Principal Investigator's opinion.

          -  Karnofsky Performance Scale ≥ 70.

          -  Measurable disease by RECIST v.1.1. Previously treated lesions are allowed as long as
             there is a new confirmed measurable component.

          -  Child-Pugh score A6 or better.

          -  Adequate organ function.

        Exclusion Criteria:

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

          -  Uncontrolled systemic bacterial, fungal, or viral infection

          -  Active malignancy other than HCC, with the exception of cholangiocarcinoma (CCA)
             without any organ involvement and with an expected survival greater than or equal to 3
             years without any treatment (exception: hormone/androgen- deprivation therapy)

          -  Active autoimmune disease requiring therapy

          -  Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction

          -  History of organ transplant

          -  Advanced HCC involving greater than half (50%) of the liver
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence rates of adverse events (AEs) after infusion of ECT204 T cells
Time Frame:28 days
Safety Issue:
Description:Safety of ECT204 T cells as assessed by the number of adverse events (AEs) after infusion.

Secondary Outcome Measures

Measure:Assess the efficacy of ECT204 T cells in subjects with advanced HCC by radiographic scans assessed according to RECIST and iRECIST criteria.
Time Frame:Up to 2 years
Safety Issue:
Description:Response rate will be assessed by radiographic scans and assessed according to RECIST and iRECIST criteria.
Measure:Determine the Maximum Concentration (Cmax) of ECT204 T cells in blood after infusion.
Time Frame:Up to 2 years
Safety Issue:
Description:Determine the degree of expansion of ECT204 T cells after infusion.
Measure:Determine the Time of Maximum Concentration (Tmax) of ECT204 T cells in blood after infusion.
Time Frame:Up to 2 years
Safety Issue:
Description:Determine the expansion kinetics of ECT204 T cells after infusion.
Measure:Determine the Area under the curve (AUC) at fixed time intervals (e.g., from Day 0 to Day 28).
Time Frame:28 days
Safety Issue:
Description:Assess the expansion and persistence of ECT204 T cells after infusion.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eureka Therapeutics Inc.

Trial Keywords

  • Hepatocellular Carcinoma HCC
  • Advanced HCC
  • Late-Stage HCC
  • Liver Cancer
  • Liver Neoplasm
  • Metastatic Liver Cancer
  • Metastatic HCC
  • T-cell therapy
  • Immunotherapy

Last Updated

July 27, 2021