Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)
Purpose
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).
Conditions
- Hepatocellular Carcinoma
- Liver Cancer
- Liver Neoplasm
- Metastatic Liver Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ET140203 TCells |
ET140203 T Cells |
|
More Details
- Status
- Terminated
- Sponsor
- Eureka Therapeutics Inc.
Study Contact
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.