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Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)

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ClinicalTrials.gov Identifier: NCT04502082
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : July 6, 2022
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Liver Cancer Liver Neoplasm Metastatic Liver Cancer Biological: ET140203 autologous T cell product Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: ET140203 TCells
ET140203 T Cells
Biological: ET140203 autologous T cell product
Autologous T cells transduced with lentivirus encoding an ET140203 expression construct

Primary Outcome Measures :
  1. Incidence rates of adverse events (AEs) after infusion of ET140203 T cells [ Time Frame: 28 days ]
    Safety of ET140203T cells as assessed by the number of adverse events (AEs) after infusion

  2. Severity rates of adverse events (AEs) after infusion of ET140203 T cells [ Time Frame: 28 days ]
    Safety of ET140203T cells as assessed by the severity of adverse events (AEs) after infusion.

  3. Incidence rates of dose limiting toxicities (DLTs) after infusion of ET140203 T cells [ Time Frame: 28 days ]
    Tolerability of ET140203T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)

  4. The recommended phase 2 dose (RP2D) regimen of ET140203 T-cell therapy primarily based on DLT [ Time Frame: 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

Secondary Outcome Measures :
  1. Assess the efficacy of ET140203 T cells in adults with advanced HCC. [ Time Frame: up to 2 years ]
    Response rate will be assessed by radiographic scans and assessed according to RECIST criteria.

  2. Determine the pharmacokinetics of ET140203 T cells after infusion. [ Time Frame: up to 2 years ]
    Assess the persistence of ET140203 T cells circulating in blood over time

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502082

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Contact: Teresa Klask, BS 925-949-9314 teresa.klask@eurekainc.com
Contact: Pei Wang, PhD 510-972-1252 pei.wang@eurekainc.com

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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Claudia Aceves (Clinical Research Coordinator)    626-218-5114    CAceves@coh.org   
Principal Investigator: Daneng Li, MD         
UC Irvine Recruiting
Irvine, California, United States, 92697
Contact: Emiri Matsuda    714-509-2710    emirim@hs.uci.edu   
Contact: Dorothy Chang    714.509.2199    dorothc@hs.uci.edu   
Principal Investigator: Farshid Dayyani, MD, Phd         
UC Davis Recruiting
Sacramento, California, United States, 95817
Contact: Laura Molnar    916-734-3089    lmmolnar@ucdavis.edu   
Contact: Christina Romo    916-734-1455    crromo@ucdavis.edu   
Principal Investigator: Edward Kim, MD, PhD         
United States, Kansas
Kansas University Medical Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Meredith Cooper    913-574-2030    mcooper5@kumc.edu   
Contact: Fizza Mahmud    913-945-6659    fmahmud@kumc.edu   
Principal Investigator: Raed Al-Rajabi, MD         
Sponsors and Collaborators
Eureka Therapeutics Inc.
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Study Director: Pei Wang, PhD Eureka Therapeutics Inc.
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Responsible Party: Eureka Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04502082    
Other Study ID Numbers: ETUS19AFPAR121
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eureka Therapeutics Inc.:
Hepatocellular Carcinoma HCC
Advanced HCC
Late-Stage HCC
Liver Cancer
Liver Neoplasm
Metastatic Liver Cancer
Metastatic HCC
T-cell therapy
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases