This is a open-label, dose escalation, multi-center, Phase I / Phase II study to assess the safety of an autologous T-cell product (ET140202) in adult subjects with advanced Alpha-fetoprotein (AFP) positive/Human Leukocyte Antigen (HLA) A-2 positive Hepatocellular Carcinoma (HCC).
The purpose of this study is to investigate a genetically modified autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ET140202 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Autologous T cells transduced with lentivirus encoding an ET140202 expression construct
City of Hope Medical Center
Duarte, California, United States
UC Irvine
Irvine, California, United States
UC Davis
Sacramento, California, United States
Incidence rates of adverse events (AEs) after infusion of ET140202 T cells
Safety and tolerability of ET140202 T cells as assessed by committee review of dose limiting toxicities (DLTs) and incidence and severity of adverse events (AEs) after infusion
Time frame: 28 days
The recommended phase 2 dose (RP2D) regimen of ET140202 T-cell therapy
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 efficacy of ET140202 T cells by overall response rate (ORR) using Response Evaluation Criteria In Solid Tumors (RECIST).
As a measure of activity, overall response rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Time frame: up to 2 years
Assess efficacy of ET140202 T cells by complete response (CR) using Response Evaluation Criteria In Solid Tumors (RECIST).
As a measure of activity, CR rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Time frame: up to 2 years
Assess efficacy of ET140202 T cells by partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST).
As a measure of activity, PR rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Time frame: up to 2 years
Assess efficacy of ET140202 T cells by progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST).
As a measure of activity, PFS rate will be assessed by radiographic scans and assessed according to RECIST criteria.
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Time frame: up to 2 years
Assess efficacy of ET140202 T cells by overall survival (OS) using Response Evaluation Criteria In Solid Tumors (RECIST).
As a measure of activity, OS rate will be assessed by radiographic scans and assessed according to RECIST criteria.
Time frame: up to 2 years
Assess the expansion of ET140202 T cells in the blood shortly after infusion.
The maximum (peak) expansion of ET140202 T cells in the blood post infusion will be determined.
Time frame: up to 2 years
Assess the persistence of ET140202 T cells circulating in blood over time.
The level of ET140202 T cells in blood will be determined to assess the persistence of ET140202 T cells during the treatment and follow-up phases of the study.
Time frame: up to 2 years