RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, dose escalation, multi-center, Phase I/II clinical trial aimed at assessing the safety and preliminary efficacy of an investigational ARTEMIS® ECT204 T-cell therapy. The trial is suitable for adult subjects (≥ 18 years of age) diagnosed with GPC3-positive HCC, who have failed or not tolerated at least two (2) different anti-HCC systemic agents.

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)

Quick Facts

Study Start:2022-03-11
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04864054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed HCC, that is unresectable, recurrent, and/or metastatic.
  2. * GPC3-positive tumor expression confirmed by immunohistochemistry (IHC).
  3. * For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC.
  4. * Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+/3+ IHC.
  5. * Must have failed, or not tolerated, at least two (2) different anti-HCC systemic agents.
  6. * Life expectancy of at least 4 months per the Investigator's opinion.
  7. * Karnofsky Performance Scale of 70 or higher.
  8. * Measurable disease by RECIST v1.1.
  9. * Child-Pugh score of A6 or better.
  10. * Adequate organ function.
  1. * Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.
  2. * Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
  3. * Active malignancy (other than HCC), with the exception of cholangiocarcinoma (CCA) or any malignancy without any organ involvement and with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen- deprivation therapy).
  4. * Pregnant or lactating women.
  5. * Currently receiving or ending (\< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.
  6. * Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
  7. * Active autoimmune disease requiring systemic immunosuppressive therapy.
  8. * Presence of portal vein tumor thrombus (PVTT) classified as grade Vp4, or any invasion into the inferior vena cava (IVC).
  9. * Ascites requiring active treatment.
  10. * History of organ transplant.
  11. * Advanced HCC involving greater than half (50%) of the liver.

Contacts and Locations

Study Contact

Teresa Klask, MBA
CONTACT
925-949-9314
Teresa.Klask@eurekainc.com
Pei Wang, PhD
CONTACT
510-654-7045
Pei.Wang@eurekainc.com

Principal Investigator

Pei Wang, PhD
STUDY_DIRECTOR
Eureka Therapeutics Inc.

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Kansas University Medical Center, Principal Investigator:
Westwood, Kansas, 66205
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States
Oregon Health and Sciences University
Portland, Oregon, 97239
United States
University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, 75235
United States
Fred Hutchinson Cancer Center, University of Washington
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Eureka Therapeutics Inc.

  • Pei Wang, PhD, STUDY_DIRECTOR, Eureka Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-11
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-03-11
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Hepatocellular Carcinoma
  • Advanced HCC
  • Late-Stage HCC
  • Liver Cancer
  • Liver Neoplasm
  • Metastatic Liver Cancer
  • Metastatic HCC
  • T-cell therapy
  • Immunotherapy
  • HCC

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma
  • Liver Cancer, Adult
  • Liver Neoplasm
  • Metastatic Liver Cancer