NCT04502082

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

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Eureka Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	ET140203 autologous T cell product	Autologous T cells transduced with lentivirus encoding an ET140203 expression construct

Timeline

• Start date: 2021-04-14
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2020-08-06
• Last updated: 2025-09-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study