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Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma Who Are Not Candidates for Standard-Of-Care Therapy (ET-109)

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ClinicalTrials.gov Identifier: NCT03998033
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Eureka Therapeutics Inc.

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).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Liver Cancer Liver Neoplasm Metastatic Liver Cancer Biological: ET140202 autologous T cell product Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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") Who Are Not Candidates for Standard-Of-Care Therapy
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : October 1, 2022

Arm Intervention/treatment
Experimental: ET140202 T cells
ET140202 Receptor (+) T Cells
Biological: ET140202 autologous T cell product
Autologous T cells transduced with lentivirus encoding an ET140202 expression construct




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent obtained prior to study procedures
  • Histologically confirmed HCC with serum AFP greater than 200 ng/ml or radiographic diagnosis of HCC with serum AFP greater than 400 ng/ml
  • Metastatic or locally advanced, unresectable HCC
  • Must have failed or not tolerated, at least one line of treatment 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998033


Contacts
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Contact: Debbie Cote +1 (510) 318-9215 debbie.cote@eurekainc.com

Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Claudia Aceves (Clinical Research Coordinator)    626-218-5114    CAceves@coh.org   
Principal Investigator: Daneng Li, MD         
Sponsors and Collaborators
Eureka Therapeutics Inc.
Investigators
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Study Director: Eureka Study Director Eureka Therapeutics

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Responsible Party: Eureka Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03998033     History of Changes
Other Study ID Numbers: ETUS19AFPAR109
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eureka Therapeutics Inc.:
Hepatocellular Carcinoma
HCC
Advanced HCC
Late-Stage HCC
Liver Cancer
Liver Neoplasm
Metastatic Liver Cancer
Metastatic HCC
T-cell therapy
Immunotherapy

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases