Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma (ET-109)

Eureka Therapeutics

Status and phase

Terminated

Phase 1

Conditions

Liver Neoplasm

Metastatic Liver Cancer

Hepatocellular Carcinoma

Liver Cancer

Treatments

Biological: ET140202 autologous T cell product

Study type

Interventional

Funder types

Industry

Identifiers

NCT03998033

ETUS18AFPAR109

Details and patient eligibility

About

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).

Full 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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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/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 (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