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)
Eureka Therapeutics Inc.
20 participants
Mar 11, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria11
- 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.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04864054