NCT03998033

Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma

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")

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Eureka Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasm
• Metastatic Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ET140202 autologous T cell product	Autologous T cells transduced with lentivirus encoding an ET140202 expression construct

Timeline

• Start date: 2019-05-30
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-06-25
• Last updated: 2022-08-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study