- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03998033
Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma (ET-109)
August 19, 2022 updated by: Eureka Therapeutics Inc.
An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140202 T Cells and Determine the Recommended Phase II Dose ("RP2D") in Adults With Advanced Hepatocellular Carcinoma ("HCC")
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).
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
2
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
Irvine, California, United States, 92697
- UC Irvine
-
Sacramento, California, United States, 95817
- UC Davis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ET140202 T cells
ET140202 Receptor (+) T Cells
|
Autologous T cells transduced with lentivirus encoding an ET140202 expression construct
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rates of adverse events (AEs) after infusion of ET140202 T cells
Time Frame: 28 days
|
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
Time Frame: up to 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess efficacy of ET140202 T cells by overall response rate (ORR) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame: up to 2 years
|
As a measure of activity, overall response rate will be assessed by radiographic scans and assessed according to RECIST criteria.
|
up to 2 years
|
Assess efficacy of ET140202 T cells by complete response (CR) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame: up to 2 years
|
As a measure of activity, CR rate will be assessed by radiographic scans and assessed according to RECIST criteria.
|
up to 2 years
|
Assess efficacy of ET140202 T cells by partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame: up to 2 years
|
As a measure of activity, PR rate will be assessed by radiographic scans and assessed according to RECIST criteria.
|
up to 2 years
|
Assess efficacy of ET140202 T cells by progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame: up to 2 years
|
As a measure of activity, PFS rate will be assessed by radiographic scans and assessed according to RECIST criteria.
|
up to 2 years
|
Assess efficacy of ET140202 T cells by overall survival (OS) using Response Evaluation Criteria In Solid Tumors (RECIST).
Time Frame: up to 2 years
|
As a measure of activity, OS rate will be assessed by radiographic scans and assessed according to RECIST criteria.
|
up to 2 years
|
Assess the expansion of ET140202 T cells in the blood shortly after infusion.
Time Frame: up to 2 years
|
The maximum (peak) expansion of ET140202 T cells in the blood post infusion will be determined.
|
up to 2 years
|
Assess the persistence of ET140202 T cells circulating in blood over time.
Time Frame: up to 2 years
|
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.
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eureka Study Director, Eureka Therapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2019
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 7, 2019
First Submitted That Met QC Criteria
June 24, 2019
First Posted (Actual)
June 25, 2019
Study Record Updates
Last Update Posted (Actual)
August 23, 2022
Last Update Submitted That Met QC Criteria
August 19, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETUS18AFPAR109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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