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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04502082
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : October 5, 2020
Sponsor:
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
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)
Estimated Study Start Date : October 12, 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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


Contacts
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Contact: Karen B Cravotto (510) 722-8719 karen.cravotto@eurekainc.com
Contact: Pei Wang, PhD 510-972-1252 pei.wang@eurekainc.com

Locations
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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 Not yet recruiting
Irvine, California, United States, 92697
Contact: Jessica Spolarich    714-509-2450    jspolari@uci.edu   
Principal Investigator: Farshid Dayyani, MD, Phd         
UC Davis Recruiting
Sacramento, California, United States, 95817
Contact: Frances N Lara    916-734-8134    fnlara@ucdavis.edu   
Contact: Marlene Alvarez    916-734-5934    msalvarez@ucdavis.edu   
Principal Investigator: Edward Kim, MD, PhD         
United States, Kansas
KU Cancer Center | Clinical Trials Office Not yet recruiting
Westwood, Kansas, United States, 66205
Contact: Richard Dugan-Starr    913-574-0481    rduganstarr@kumc.edu   
Contact: Jeffrey Roesgen    913-945-8679    jroesgen@kumc.edu   
Principal Investigator: Raed Al-Rajabi, MD         
Sponsors and Collaborators
Eureka Therapeutics Inc.
Investigators
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Study Director: Karen B Cravotto 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: October 5, 2020
Last Verified: September 2020
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
Immunotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases