Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma

Stopped early · Phase 1

Conditions studied: Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasm, Metastatic Liver Cancer

In brief

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).

Key facts

Study ID

NCT03998033

Run by

Eureka Therapeutics Inc.

People needed

2

Starts

2019-05-30

Expected to finish

2020-12-31

Last updated by the study team

2022-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• UC Irvine — Irvine, California, United States
• UC Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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