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).
The purpose of this study is to investigate an autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ET140203 T cells are autologous T cells genetically modified to carry a TCR-mimic (TCRm) construct capable of mediating cell killing by targeting tumor specific intracellular antigens and addressing solid tumor therapy challenges. 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 their efforts to the pediatric study (ARYA-2) for this product.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Autologous T cells transduced with lentivirus encoding an ET140203 expression construct
City of Hope Medical Center
Duarte, California, United States
Kansas University Medical Center
Westwood, Kansas, United States
Incidence rates of adverse events (AEs) after infusion of ET140203 T cells
Safety of ET140203T cells as assessed by the number of adverse events (AEs) after infusion
Time frame: 28 days
Severity rates of adverse events (AEs) after infusion of ET140203 T cells
Safety of ET140203T cells as assessed by the severity of adverse events (AEs) after infusion.
Time frame: 28 days
Incidence rates of dose limiting toxicities (DLTs) after infusion of ET140203 T cells
Tolerability of ET140203T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)
Time frame: 28 days
The recommended phase 2 dose (RP2D) regimen of ET140203 T-cell therapy primarily based on DLT
The RP2D will be determined by the study Dose Escalation Committee (DEC) and primarily based on DLT, and secondarily on the best tumor response
Time frame: up to 2 years
Assess the efficacy of ET140203 T cells in adults with advanced HCC.
Response rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Time frame: up to 2 years
Determine the pharmacokinetics of ET140203 T cells after infusion.
Assess the persistence of ET140203 T cells circulating in blood over time
Time frame: up to 2 years
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