Hepatocellular Carcinoma Clinical Trial
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)
This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy, referred to as ECT204. This trial is suitable for 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. Phase I has concluded and a Recommended Phase II Dose (RP2D) has been determined. We are now conducting Phase II to further confirm the safety profile and efficacy of ECT204.
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. Part 1 - Dose Escalation Phase: A traditional dose escalation model (3+3 design) was used to determine the RP2D of ECT204. ** Part 1 was completed on December 20, 2023 ** Part 2 - Expansion Phase: The expansion phase includes 2 study arms. Arm A: Subjects will receive ECT204 at the RP2D to further confirm the safety profile of ECT204 and evaluate the preliminary efficacy of ECT204. Arm B: Subjects will be administered regorafenib prior to receiving ECT204 at the RP2D to assess the safety and efficacy of ECT204 following regorafenib pre-treatment. The active assessment period of the study will continue for 2 years. Subjects will be followed for assessment of treatment safety and overall survival during Long Term Follow-Up (LTFU; year 2 -15). ;
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