NCT04502082

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

3.4 years

First QC Date

July 22, 2020

Last Update Submit

September 1, 2025

Conditions

Hepatocellular CarcinomaLiver CancerLiver NeoplasmMetastatic Liver Cancer

Keywords

Hepatocellular Carcinoma HCCAdvanced HCCLate-Stage HCCLiver CancerLiver NeoplasmMetastatic Liver CancerMetastatic HCCT-cell therapyImmunotherapy

Outcome Measures

Primary Outcomes (4)

  • 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

    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.

    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)

    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

    up to 2 years

Secondary Outcomes (2)

  • Assess the efficacy of ET140203 T cells in adults with advanced HCC.

    up to 2 years

  • Determine the pharmacokinetics of ET140203 T cells after infusion.

    up to 2 years

Study Arms (1)

ET140203 TCells

EXPERIMENTAL

ET140203 T Cells

Biological: ET140203 autologous T cell product

Interventions

ET140203 autologous T cell productBIOLOGICAL

Autologous T cells transduced with lentivirus encoding an ET140203 expression construct

ET140203 TCells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed HCC with serum AFP \>100ng/ml at time of screening and following most current line of therapy OR radiographic diagnosis of HCC with serum AFP \>400ng/ml at time of screening and following most current line of therapy.
  • Metastatic or locally advanced, unresectable HCC
  • Must have failed or not tolerated at least two (2) different anti-HCC systemic agents
  • Molecular Human Leukocyte Antigen ("HLA") class I allele typing confirms participant carries at least one HLA-A2 allele
  • Life expectancy of at least 4 months
  • Karnofsky Performance Scale greater than or equal to 70
  • At least 1 measurable lesion on imaging by RECIST
  • Child-Pugh A6 or better
  • Absolute neutrophil count greater than or equal to 1,500/mm\^3
  • Platelet count greater than or equal to 75,000/mm\^3

You may not qualify if:

  • Clinically significant cardiac disease
  • Clinically significant pre-existing illness or active infection
  • Clinically significant Central Nervous System (CNS) or neural dysfunction
  • Active autoimmune disease requiring therapy
  • Active malignancy other than HCC with the exception of cholangiocarcinoma (CCA) or any malignancy with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen-deprivation therapy) and without any organ involvement
  • History of organ transplant
  • Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction
  • Advanced HCC involving greater than 50% of the liver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Kansas University Medical Center

Westwood, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Pei Wang, PhD

    Eureka Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Sequential Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

August 6, 2020

Study Start

April 14, 2021

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)