An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC)
Eureka Therapeutics Inc.
Summary
This is an open-label, multi-center, Phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of ECT204, an investigational ARTEMIS® T-cell therapy, in adult subjects with GPC3-positive hepatocellular carcinoma (HCC) who have experienced disease progression on, or intolerance to, prior systemic therapy.
Description
ECT204 is an autologous T-cell product built on the ARTEMIS® Cell Receptor platform, incorporating two GPC3-targeting surface components: an antibody-T-cell receptor (AbTCR) and a chimeric stimulating receptor (CSR). Each subject's T cells are collected and genetically modified ex vivo to co-express these receptors, then re-administered to selectively recognize and eliminate GPC3-expressing HCC tumor cells. The study consists of a completed Phase 1 and a Phase 2 expansion cohort. Phase 1 used a traditional 3+3 dose-escalation design to determine the recommended Phase 2 dose (RP2D), followed b…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 received at least first-line systemic therapy for HCC and have experienced disease progression on, or intolerance to, that therapy. * Life expectancy of at least 4 months per the Investigator's opinion. * Eastern Cooperative Oncology Group (ECOG) performance stat…
Interventions
- BiologicalECT204 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 (8)
- City of HopeDuarte, California
- Kansas University Medical Center, Principal Investigator:Westwood, Kansas
- Roswell Park Comprehensive Cancer CenterBuffalo, New York
- Montefiore Einstein Comprehensive Cancer CenterThe Bronx, New York
- Oregon Health and Sciences UniversityPortland, Oregon
- University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer CenterDallas, Texas