Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion
Principal Investigator
Farshid Dayyani, MD, Phd

Description

Summary

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).

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")

Details

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.

Keywords

Hepatocellular Carcinoma Liver Cancer Liver Neoplasm Metastatic Liver Cancer HCC Advanced HCC Late-Stage HCC Metastatic HCC T-cell therapy Immunotherapy Carcinoma Carcinoma, Hepatocellular Liver Neoplasms ET140202 autologous T cell product ET140202 T cells

Eligibility

You can join if…

Open to people ages 18 years and up

  • Signed written informed consent obtained prior to study procedures
  • 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 one line of systemic therapy 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/mm3

  • Platelet count greater than or equal to 30,000/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 unless expected survival is greater than or equal to three years without any treatment (exception: hormone/androgen-depravation 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

Locations

  • UC Irvine accepting new patients
    Irvine California 92697 United States
  • City of Hope Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eureka Therapeutics Inc.
ID
NCT03998033
Phase
Phase 1/2
Study Type
Interventional
Last Updated