RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
T-Cell Therapy (ECT204) in Adults With Advanced HCC
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- diagnosed by tissue sample (biopsy-confirmed) HCC, that is unresectable, recurrent, and/or metastatic.
- GPC3-positive tumor expression confirmed by immunohistochemistry (IHC).
- For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC.
- Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+/3+ IHC.
- Must have failed, or not tolerated, at least two (2) different anti-HCC systemic agents.
- expected to live at least 4 months per the Investigator's opinion.
- Karnofsky Performance Scale of 70 or higher.
- Measurable disease by RECIST v1.1.
- Child-Pugh score of A6 or better.
- your organs (liver, kidneys, etc.) are working well enough based on blood tests.
Who Should NOT Join This Trial:
- Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.
- Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human weakened immune system Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
- 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).
- Pregnant or lactating women.
- Currently receiving or ending (\< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.
- Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
- Active autoimmune conditions (where your immune system attacks your own body) requiring systemic immunosuppressive therapy.
- Presence of portal vein tumor thrombus (PVTT) classified as grade Vp4, or any invasion into the inferior vena cava (IVC).
- Ascites requiring active treatment.
- History of organ transplant.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Histologically confirmed HCC, that is unresectable, recurrent, and/or metastatic.
* GPC3-positive tumor expression confirmed by immunohistochemistry (IHC).
* For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC.
* Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+/3+ IHC.
* Must have failed, or not tolerated, at least two (2) different anti-HCC systemic agents.
* Life expectancy of at least 4 months per the Investigator's opinion.
* Karnofsky Performance Scale of 70 or higher.
* Measurable disease by RECIST v1.1.
* Child-Pugh score of A6 or better.
* Adequate organ function.
Exclusion Criteria:
* Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.
* 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.
* 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).
* Pregnant or lactating women.
* Currently receiving or ending (\< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.
* Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
* Active autoimmune disease requiring systemic immunosuppressive therapy.
* Presence of portal vein tumor thrombus (PVTT) classified as grade Vp4, or any invasion into the inferior vena cava (IVC).
* Ascites requiring active treatment.
* History of organ transplant.
* Advanced HCC involving greater than half (50%) of the liver.
Treatments Being Tested
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.
Locations (7)
City of Hope
Duarte, California, United States
Kansas University Medical Center, Principal Investigator:
Westwood, Kansas, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States
Fred Hutchinson Cancer Center, University of Washington
Seattle, Washington, United States
National Taiwan University Cancer Center
Taipei, Taiwan