Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma

NCT ID: NCT03998033

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2020-12-31

Brief 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

Study Design

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

Study Groups

ET140202 T cells

ET140202 Receptor (+) T Cells

Group Type: EXPERIMENTAL

ET140202 autologous T cell product

Intervention Type: BIOLOGICAL

Autologous T cells transduced with lentivirus encoding an ET140202 expression construct

Interventions

ET140202 autologous T cell product

Autologous T cells transduced with lentivirus encoding an ET140202 expression construct

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• 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

Eureka Study Director

Role: STUDY_DIRECTOR

Eureka Therapeutics

Locations

City of Hope Medical Center

Duarte, California, United States

UC Irvine

Irvine, California, United States

UC Davis

Sacramento, California, United States

Countries

United States

Other Identifiers

ETUS18AFPAR109

Identifier Type: -

Identifier Source: org_study_id