Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)
- Conditions
- Liver CancerHepatocellular CarcinomaLiver NeoplasmMetastatic Liver Cancer
- Interventions
- Biological: ET140203 autologous T cell product
- Registration Number
- NCT04502082
- Lead Sponsor
- Eureka Therapeutics Inc.
- 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 Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ET140203 TCells ET140203 autologous T cell product ET140203 T Cells
- Primary Outcome Measures
Name Time Method The recommended phase 2 dose (RP2D) regimen of ET140203 T-cell therapy primarily based on DLT up to 2 years The RP2D will be determined by the study Dose Escalation Committee (DEC) and primarily based on DLT, and secondarily on the best tumor response
Incidence rates of adverse events (AEs) after infusion of ET140203 T cells 28 days Safety of ET140203T cells as assessed by the number of adverse events (AEs) after infusion
Severity rates of adverse events (AEs) after infusion of ET140203 T cells 28 days Safety of ET140203T cells as assessed by the severity of adverse events (AEs) after infusion.
Incidence rates of dose limiting toxicities (DLTs) after infusion of ET140203 T cells 28 days Tolerability of ET140203T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)
- Secondary Outcome Measures
Name Time Method Assess the efficacy of ET140203 T cells in adults with advanced HCC. up to 2 years Response rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Determine the pharmacokinetics of ET140203 T cells after infusion. up to 2 years Assess the persistence of ET140203 T cells circulating in blood over time
Trial Locations
- Locations (2)
City of Hope Medical Center
🇺🇸Duarte, California, United States
Kansas University Medical Center
🇺🇸Westwood, Kansas, United States