Description:
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).
Title
- Brief Title: Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)
- Official Title: An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140203 T Cells and Determine the Recommended Phase II Dose (RP2D) in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-1)
Clinical Trial IDs
- ORG STUDY ID:
ETUS19AFPAR121
- NCT ID:
NCT04502082
Conditions
- Hepatocellular Carcinoma
- Liver Cancer
- Liver Neoplasm
- Metastatic Liver Cancer
Interventions
Drug | Synonyms | Arms |
---|
ET140203 autologous T cell product | | ET140203 TCells |
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).
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.
Trial Arms
Name | Type | Description | Interventions |
---|
ET140203 TCells | Experimental | ET140203 T Cells | - ET140203 autologous T cell product
|
Eligibility Criteria
Inclusion Criteria:
- 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 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 A or B7
- Absolute neutrophil count greater than or equal to 1,500/mm^3
- Platelet count greater than or equal to 60,000/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-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 one-third of the liver
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence rates of adverse events (AEs) after infusion of ET140203 T cells |
Time Frame: | 28 days |
Safety Issue: | |
Description: | Safety of ET140203T cells as assessed by the number of adverse events (AEs) after infusion |
Secondary Outcome Measures
Measure: | Assess the efficacy of ET140203 T cells in adults with advanced HCC. |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Response rate will be assessed by radiographic scans and assessed according to RECIST criteria. |
Measure: | Determine the pharmacokinetics of ET140203 T cells after infusion. |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Assess the persistence of ET140203 T cells circulating in blood over time |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Eureka Therapeutics Inc. |
Trial Keywords
- Hepatocellular Carcinoma HCC
- Advanced HCC
- Late-Stage HCC
- Liver Cancer
- Liver Neoplasm
- Metastatic Liver Cancer
- Metastatic HCC
- T-cell therapy
- Immunotherapy
Last Updated
May 25, 2021