NCT03998033

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started May 2019

Shorter than P25 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

May 30, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

June 7, 2019

Last Update Submit

August 19, 2022

Conditions

Hepatocellular CarcinomaLiver CancerLiver NeoplasmMetastatic Liver Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    up to 2 years

Secondary Outcomes (7)

  • Assess efficacy of ET140202 T cells by overall response rate (ORR) using Response Evaluation Criteria In Solid Tumors (RECIST).

    up to 2 years

  • Assess efficacy of ET140202 T cells by complete response (CR) using Response Evaluation Criteria In Solid Tumors (RECIST).

    up to 2 years

  • Assess efficacy of ET140202 T cells by partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST).

    up to 2 years

  • Assess efficacy of ET140202 T cells by progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST).

    up to 2 years

  • Assess efficacy of ET140202 T cells by overall survival (OS) using Response Evaluation Criteria In Solid Tumors (RECIST).

    up to 2 years

  • +2 more secondary outcomes

Study Arms (1)

ET140202 T cells

EXPERIMENTAL

ET140202 Receptor (+) T Cells

Biological: ET140202 autologous T cell product

Interventions

ET140202 autologous T cell productBIOLOGICAL

Autologous T cells transduced with lentivirus encoding an ET140202 expression construct

ET140202 T cells

Eligibility Criteria

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

You may qualify if:

  • Signed written informed consent obtained prior to study procedures
  • Histologically confirmed HCC with serum AFP \>200ng/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 one line of systemic therapy for advanced HCC
  • 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 A or B7
  • Absolute neutrophil count greater than or equal to 1,500/mm\^3
  • Platelet count greater than or equal to 30,000/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 unless expected survival is greater than or equal to three years without any treatment (exception: hormone/androgen-depravation 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 one-third of the liver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

UC Irvine

Irvine, California, 92697, United States

Location

UC Davis

Sacramento, California, 95817, 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

  • Eureka Study Director

    Eureka Therapeutics

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 25, 2019

Study Start

May 30, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)