Clinical Trials /

Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ET121)

NCT04502082

Description:

Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ET121)
  • Official Title: An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140203 T Cells and Determine the Recommended Phase II Dose (RP2D) in Adults With Advanced Hepatocellular Carcinoma (HCC)

Clinical Trial IDs

  • ORG STUDY ID: ETUS19AFPAR121
  • NCT ID: NCT04502082

Conditions

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Liver Neoplasm
  • Metastatic Liver Cancer

Interventions

DrugSynonymsArms
ET140203 autologous T cell productET140203 TCells

Purpose

Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).

Detailed Description

      The purpose of this study is to investigate an autologous T-cell therapy for advanced
      hepatocellular carcinoma (HCC). ET140203 T cells are autologous T cells genetically modified
      to carry a TCR-mimic (TCRm) construct capable of mediating cell killing by targeting tumor
      specific intracellular antigens and addressing solid tumor therapy challenges.
    

Trial Arms

NameTypeDescriptionInterventions
ET140203 TCellsExperimentalET140203 T Cells
  • ET140203 autologous T cell product

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed HCC with serum AFP >200ng/ml at time of screening and
             following most current line of therapy OR radiographic diagnosis of HCC with serum AFP
             >400ng/ml at time of screening and following most current line of therapy.

          -  Metastatic or locally advanced, unresectable HCC

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

          -  Molecular Human Leukocyte Antigen ("HLA") class I allele typing confirms participant
             carries at least one HLA-A2 allele

          -  Life expectancy of at least 4 months

          -  Karnofsky Performance Scale greater than or equal to 70

          -  At least 1 measurable lesion on imaging by RECIST

          -  Child-Pugh A or B7

          -  Absolute neutrophil count greater than or equal to 1,500/mm^3

          -  Platelet count greater than or equal to 60,000/mm^3

        Exclusion Criteria:

          -  Clinically significant cardiac disease

          -  Clinically significant pre-existing illness or active infection

          -  Clinically significant Central Nervous System (CNS) or neural dysfunction

          -  Active autoimmune disease requiring therapy

          -  Active malignancy other than HCC unless expected survival is greater than or equal to
             three years without any treatment (exception: hormone/androgen-deprivation therapy)
             and without any organ involvement

          -  History of organ transplant

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

          -  Advanced HCC involving greater than one-third 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 ET140203 T cells
Time Frame:28 days
Safety Issue:
Description:Safety of ET140203T cells as assessed by the number of adverse events (AEs) after infusion

Secondary Outcome Measures

Measure:Assess the efficacy of ET140203 T cells in adults with advanced HCC.
Time Frame:up to 2 years
Safety Issue:
Description:Response rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Measure:Determine the pharmacokinetics of ET140203 T cells after infusion.
Time Frame:up to 2 years
Safety Issue:
Description:Assess the persistence of ET140203 T cells circulating in blood over time

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet 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

August 3, 2020