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ECT204 T-Cell Therapy in Adults With Advanced HCC (ARYA3)

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ClinicalTrials.gov Identifier: NCT04864054
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Eureka Therapeutics Inc.

Brief Summary:
This will be an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of ECT204 T-cell therapy and determine the RP2D in adult subjects (≥ 18 years of age) who have GPC3-positive HCC and have failed or not tolerated at least two (2) different anti-HCC systemic agents.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Liver Cancer, Adult Liver Neoplasm Metastatic Liver Cancer Biological: ECT204 T cells Phase 1 Phase 2

Detailed Description:
The purpose of this study is to investigate an autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ECT204 T cells are autologous T cells genetically modified to carry a construct capable of mediating cell killing by targeting tumor specific antigens.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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 Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-3)
Estimated Study Start Date : August 15, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : July 31, 2024

Arm Intervention/treatment
Experimental: ECT204
A minimum of twelve (12) subjects will be treated to determine the RP2D.
Biological: ECT204 T cells
ECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.




Primary Outcome Measures :
  1. Incidence rates of adverse events (AEs) after infusion of ECT204 T cells [ Time Frame: 28 days ]
    Safety of ECT204 T cells as assessed by the number of adverse events (AEs) after infusion.

  2. Severity rates of adverse events (AEs) after infusion of ECT204 T cells [ Time Frame: 28 days ]
    Safety of ECT204 T cells as assessed by the severity of adverse events (AEs) after infusion.

  3. Incidence rates of dose limiting toxicities (DLTs) after infusion of ECT204 T cells [ Time Frame: 28 days ]
    Tolerability of ECT204 T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)

  4. The recommended phase 2 dose (RP2D) of ECT204 T cells [ Time Frame: Up to 2 years ]

    The RP2D will be determined by the study Dose Escalation Committee (DEC) and chosen

    based on the maximum tolerated dose (MTD) but will not exceed the MTD and the maximum administered dose (MAD).



Secondary Outcome Measures :
  1. Assess the efficacy of ECT204 T cells in subjects with advanced HCC by radiographic scans assessed according to RECIST and iRECIST criteria. [ Time Frame: Up to 2 years ]
    Response rate will be assessed by radiographic scans and assessed according to RECIST and iRECIST criteria.

  2. Determine the Maximum Concentration (Cmax) of ECT204 T cells in blood after infusion. [ Time Frame: Up to 2 years ]
    Determine the degree of expansion of ECT204 T cells after infusion.

  3. Determine the Time of Maximum Concentration (Tmax) of ECT204 T cells in blood after infusion. [ Time Frame: Up to 2 years ]
    Determine the expansion kinetics of ECT204 T cells after infusion.

  4. Determine the Area under the curve (AUC) at fixed time intervals (e.g., from Day 0 to Day 28). [ Time Frame: 28 days ]
    Assess the expansion and persistence of ECT204 T cells after infusion.



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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, which is unresectable, recurrent and/or metastatic.
  • GPC3-positive expression in HCC tumor cells by immunohistochemistry (IHC).
  • Must have failed or not tolerated at least two (2) different anti-HCC systemic agents.
  • Life expectancy of at least 4 months per Principal Investigator's opinion.
  • Karnofsky Performance Scale ≥ 70.
  • Measurable disease by RECIST v.1.1. Previously treated lesions are allowed as long as there is a new confirmed measurable component.
  • Child-Pugh score A6 or better.
  • Adequate organ function.

Exclusion Criteria:

  • Clinically significant pre-existing illness (e.g., heart failure)
  • Uncontrolled systemic bacterial, fungal, or viral infection
  • Active malignancy other than HCC, with the exception of cholangiocarcinoma (CCA) without any organ involvement and with an expected survival greater than or equal to 3 years without any treatment (exception: hormone/androgen- deprivation therapy)
  • Active autoimmune disease requiring therapy
  • Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction
  • History of organ transplant
  • Advanced HCC involving greater than half (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): NCT04864054


Contacts
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Contact: Karen B Cravotto 510-722-8719 karen.cravotto@eurekainc.com
Contact: Pei Wang, PhD 510-654-7045 pei.wang@eurekainc.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Claudia Aceves    626-218-5114    CAceves@coh.org   
Principal Investigator: Daneng Li, MD         
United States, Kansas
Kansas University Cancer Center Not yet recruiting
Westwood, Kansas, United States, 66205
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: Pei Wang, PhD Eureka Therapeutics Inc.
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Responsible Party: Eureka Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04864054    
Other Study ID Numbers: ETUS20GPC3AR124
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: March 2021

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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