A Study of Experimental ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (Liver Cancer)

a study on Hepatocellular Cancer Liver Cancer Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Duarte, California and other locations
Dates
study started
completion

Description

Summary

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).

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) (ARYA-1)

Details

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.

Keywords

Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasm, Metastatic Liver Cancer, Hepatocellular Carcinoma HCC, Advanced HCC, Late-Stage HCC, Metastatic HCC, T-cell therapy, Immunotherapy, Carcinoma, Liver Neoplasms, ET140203 autologous T cell product, ET140203 TCells

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed HCC with serum AFP >100ng/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 A6 or better
  • Absolute neutrophil count greater than or equal to 1,500/mm3
  • Platelet count greater than or equal to 75,000/mm3

You CAN'T join if...

  • 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 with the exception of cholangiocarcinoma (CCA) or any malignancy with an expected survival ≥ 3 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 50% of the liver

Locations

  • City of Hope Medical Center
    Duarte California 91010 United States
  • Kansas University Medical Center
    Westwood Kansas 66205 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Eureka Therapeutics Inc.
Links
Sign up for this study
ID
NCT04502082
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 6 people participating
Last Updated