Status:
TERMINATED
Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)
Lead Sponsor:
Eureka Therapeutics Inc.
Conditions:
Hepatocellular Carcinoma
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 An...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04502082
Start Date
April 14 2021
End Date
August 30 2024
Last Update
September 8 2025
Active Locations (2)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
Kansas University Medical Center
Westwood, Kansas, United States, 66205