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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 : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Eureka Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE July 22, 2020
First Posted Date  ICMJE August 6, 2020
Last Update Posted Date November 15, 2021
Actual Study Start Date  ICMJE April 14, 2021
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • 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
  • 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.
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:
Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Liver Cancer
  • Liver Neoplasm
  • Metastatic Liver Cancer
Intervention  ICMJE Biological: ET140203 autologous T cell product
Autologous T cells transduced with lentivirus encoding an ET140203 expression construct
Study Arms  ICMJE Experimental: ET140203 TCells
ET140203 T Cells
Intervention: Biological: ET140203 autologous T cell product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen B Cravotto (510) 722-8719 karen.cravotto@eurekainc.com
Contact: Pei Wang, PhD 510-972-1252 pei.wang@eurekainc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04502082
Other Study ID Numbers  ICMJE ETUS19AFPAR121
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eureka Therapeutics Inc.
Study Sponsor  ICMJE Eureka Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karen B Cravotto Eureka Therapeutics Inc.
PRS Account Eureka Therapeutics Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP