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

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 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.

Conditions7

Interventions1

Locations6 sites

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