Stopped: The trial was intended to be a Phase 1/2 trial, but the sponsor terminated the trial prior to moving to Phase 2 to direct efforts to the pediatric study (ARYA-2) for this product.
Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).
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Incidence rates of adverse events (AEs) after infusion of ET140203 T cells
Timeframe: 28 days
Severity rates of adverse events (AEs) after infusion of ET140203 T cells
Timeframe: 28 days
Incidence rates of dose limiting toxicities (DLTs) after infusion of ET140203 T cells
Timeframe: 28 days
The recommended phase 2 dose (RP2D) regimen of ET140203 T-cell therapy primarily based on DLT
Timeframe: up to 2 years