Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)

Eureka Therapeutics

Status and phase

Terminated

Phase 1

Conditions

Liver Neoplasm

Metastatic Liver Cancer

Hepatocellular Carcinoma

Liver Cancer

Treatments

Biological: ET140203 autologous T cell product

Study type

Interventional

Funder types

Industry

Identifiers

NCT04502082

ETUS19AFPAR121

Details and patient eligibility

About

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).

Full 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.

The trial was intended to be a Phase 1/2 trial, but the sponsor terminated the trial prior to moving to Phase 2 to direct their efforts to the pediatric study (ARYA-2) for this product.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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/mm^3
Platelet count greater than or equal to 75,000/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 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