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

NCT ID: NCT04502082

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2024-08-30

Brief 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).

Detailed 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.

Conditions

Hepatocellular Carcinoma; Liver Cancer; Liver Neoplasm; Metastatic Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ET140203 TCells

ET140203 T Cells

Group Type: EXPERIMENTAL

ET140203 autologous T cell product

Intervention Type: BIOLOGICAL

Autologous T cells transduced with lentivirus encoding an ET140203 expression construct

Interventions

ET140203 autologous T cell product

Autologous T cells transduced with lentivirus encoding an ET140203 expression construct

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eureka Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei Wang, PhD

Role: STUDY_DIRECTOR

Eureka Therapeutics Inc.

Locations

City of Hope Medical Center

Duarte, California, United States

Kansas University Medical Center

Westwood, Kansas, United States

Countries

United States

Other Identifiers

ETUS19AFPAR121

Identifier Type: -

Identifier Source: org_study_id