Clinical Trials /

Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma

NCT03998033

Description:

This is a open-label, dose escalation, multi-center, Phase I / Phase II study to assess the safety of an autologous T-cell product (ET140202) in adult subjects with advanced Alpha-fetoprotein (AFP) positive/Human Leukocyte Antigen (HLA) A-2 positive Hepatocellular Carcinoma (HCC).

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma Who Are Not Candidates for Standard-Of-Care Therapy
  • Official Title: An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140202 T Cells and Determine the Recommended Phase II Dose ("RP2D") in Adults With Advanced Hepatocellular Carcinoma ("HCC") Who Are Not Candidates for Standard-Of-Care Therapy

Clinical Trial IDs

  • ORG STUDY ID: ETUS19AFPAR109
  • NCT ID: NCT03998033

Conditions

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

Interventions

DrugSynonymsArms
ET140202 autologous T cell productET140202 T cells

Purpose

This is a open-label, dose escalation, multi-center, Phase I / Phase II study to assess the safety of an autologous T-cell product (ET140202) in adult subjects with advanced Alpha-fetoprotein (AFP) positive/Human Leukocyte Antigen (HLA) A-2 positive Hepatocellular Carcinoma (HCC).

Detailed Description

      The purpose of this study is to investigate a genetically modified autologous T-cell therapy
      for advanced hepatocellular carcinoma (HCC). ET140202 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
ET140202 T cellsExperimentalET140202 Receptor (+) T Cells
  • ET140202 autologous T cell product

Eligibility Criteria

        Inclusion Criteria:

          -  Signed written informed consent obtained prior to study procedures

          -  Histologically confirmed HCC with serum AFP greater than 200 ng/ml or radiographic
             diagnosis of HCC with serum AFP greater than 400 ng/ml

          -  Metastatic or locally advanced, unresectable HCC

          -  Must have failed or not tolerated, at least one line of treatment for advanced HCC

          -  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 30,000/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 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 ET140202 T cells
Time Frame:28 days
Safety Issue:
Description:Safety and tolerability of ET140202 T cells as assessed by committee review of dose limiting toxicities (DLTs) and incidence and severity of adverse events (AEs) after infusion

Secondary Outcome Measures

Measure:Assess efficacy of ET140202 T cells by overall response rate (ORR) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame:up to 2 years
Safety Issue:
Description:As a measure of activity, overall response rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Measure:Assess efficacy of ET140202 T cells by complete response (CR) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame:up to 2 years
Safety Issue:
Description:As a measure of activity, CR rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Measure:Assess efficacy of ET140202 T cells by partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame:up to 2 years
Safety Issue:
Description:As a measure of activity, PR rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Measure:Assess efficacy of ET140202 T cells by progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame:up to 2 years
Safety Issue:
Description:As a measure of activity, PFS rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Measure:Assess efficacy of ET140202 T cells by overall survival (OS) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame:up to 2 years
Safety Issue:
Description:As a measure of activity, OS rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Measure:Assess the expansion of ET140202 T cells circulating in blood over time
Time Frame:up to 2 years
Safety Issue:
Description:The level of ET140202 T cells in blood will be determined to assess the expansion of ET140202 T cells during the treatment and follow-up phases of the study.
Measure:Assess the persistence of ET140202 T cells circulating in blood over time
Time Frame:up to 2 years
Safety Issue:
Description:The level of ET140202 T cells in blood will be determined to assess the persistence of ET140202 T cells during the treatment and follow-up phases of the study.

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

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