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ECT204 T-Cell Therapy in Adults With Advanced HCC (ARYA3)

Primary Purpose

Hepatocellular Carcinoma, Liver Cancer, Adult, Liver Neoplasm

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ECT204 T cells

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma HCC, Advanced HCC, Late-Stage HCC, Liver Cancer, Liver Neoplasm, Metastatic Liver Cancer, Metastatic HCC, T-cell therapy, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed HCC, which is unresectable, recurrent and/or metastatic.
GPC3-positive expression in HCC tumor cells by immunohistochemistry (IHC).
Must have failed or not tolerated at least two (2) different anti-HCC systemic agents.
Life expectancy of at least 4 months per Principal Investigator's opinion.
Karnofsky Performance Scale ≥ 70.
Measurable disease by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v.1.1). Previously treated lesions are allowed as long as there is a new confirmed measurable component.
Child-Pugh score of A6 or better.
Adequate organ function.

Exclusion Criteria:

Clinically significant pre-existing illness (e.g., heart failure)
Active, uncontrolled systemic bacterial, fungal, or viral infection
Active malignancy other than HCC, with the exception of cholangiocarcinoma (CCA) without any organ involvement and with an expected survival greater than or equal to 3 years without any treatment (exception: hormone/androgen- deprivation therapy)
Currently receiving or ending (< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.
Active autoimmune disease requiring therapy
Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction
History of organ transplant
Advanced HCC involving greater than half (50%) of the liver

Sites / Locations

City of HopeRecruiting
Kansas University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ECT204

Arm Description

Approximately twelve (12) subjects will be treated to determine the RP2D.

Outcomes

Primary Outcome Measures

Incidence rates of adverse events (AEs) after infusion of ECT204 T cells

Safety of ECT204 T cells as assessed by the number of adverse events (AEs) after infusion.

Severity rates of adverse events (AEs) after infusion of ECT204 T cells

Safety of ECT204 T cells as assessed by the severity of adverse events (AEs) after infusion.

Incidence rates of dose limiting toxicities (DLTs) after infusion of ECT204 T cells

Tolerability of ECT204 T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)

The recommended phase 2 dose (RP2D) of ECT204 T cells

The RP2D will be determined by the study Dose Escalation Committee (DEC) and chosen based on the maximum tolerated dose (MTD) but will not exceed the MTD and the maximum administered dose (MAD).

Secondary Outcome Measures

Assess the efficacy of ECT204 T cells in subjects with advanced HCC by radiographic scans assessed according to RECIST and iRECIST criteria.

Response rate will be assessed by radiographic scans and assessed according to RECIST and iRECIST criteria.

Determine the Maximum Concentration (Cmax) of ECT204 T cells in blood after infusion.

Determine the degree of expansion of ECT204 T cells after infusion.

Determine the Time of Maximum Concentration (Tmax) of ECT204 T cells in blood after infusion.

Determine the expansion kinetics of ECT204 T cells after infusion.

Determine the Area under the curve (AUC) at fixed time intervals (e.g., from Day 0 to Day 28).

Assess the expansion and persistence of ECT204 T cells after infusion.

Full Information

NCT ID

NCT04864054

First Posted

April 14, 2021

Last Updated

May 31, 2023

Sponsor

Eureka Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04864054

Brief Title

ECT204 T-Cell Therapy in Adults With Advanced HCC

Acronym

ARYA3

Official Title

An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-3)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 11, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eureka Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This will be an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of ECT204 T-cell therapy and determine the RP2D in adult subjects (≥ 18 years of age) who have GPC3-positive HCC and have failed or not tolerated at least two (2) different anti-HCC systemic agents.

Detailed Description

The purpose of this study is to investigate an autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ECT204 T cells are autologous T cells genetically modified to carry a construct capable of mediating cell killing by targeting tumor specific antigens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Liver Cancer, Adult, Liver Neoplasm, Metastatic Liver Cancer

Keywords

Hepatocellular Carcinoma HCC, Advanced HCC, Late-Stage HCC, Liver Cancer, Liver Neoplasm, Metastatic Liver Cancer, Metastatic HCC, T-cell therapy, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

Sequential assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ECT204

Arm Type

Experimental

Arm Description

Approximately twelve (12) subjects will be treated to determine the RP2D.

Intervention Type

Biological

Intervention Name(s)

ECT204 T cells

Intervention Description

ECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.

Primary Outcome Measure Information:

Title

Incidence rates of adverse events (AEs) after infusion of ECT204 T cells

Description

Safety of ECT204 T cells as assessed by the number of adverse events (AEs) after infusion.

Time Frame

28 days

Title

Severity rates of adverse events (AEs) after infusion of ECT204 T cells

Description

Safety of ECT204 T cells as assessed by the severity of adverse events (AEs) after infusion.

Time Frame

28 days

Title

Incidence rates of dose limiting toxicities (DLTs) after infusion of ECT204 T cells

Description

Tolerability of ECT204 T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)

Time Frame

28 days

Title

The recommended phase 2 dose (RP2D) of ECT204 T cells

Description

The RP2D will be determined by the study Dose Escalation Committee (DEC) and chosen based on the maximum tolerated dose (MTD) but will not exceed the MTD and the maximum administered dose (MAD).

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Assess the efficacy of ECT204 T cells in subjects with advanced HCC by radiographic scans assessed according to RECIST and iRECIST criteria.

Description

Response rate will be assessed by radiographic scans and assessed according to RECIST and iRECIST criteria.

Time Frame

Up to 2 years

Title

Determine the Maximum Concentration (Cmax) of ECT204 T cells in blood after infusion.

Description

Determine the degree of expansion of ECT204 T cells after infusion.

Time Frame

Up to 2 years

Title

Determine the Time of Maximum Concentration (Tmax) of ECT204 T cells in blood after infusion.

Description

Determine the expansion kinetics of ECT204 T cells after infusion.

Time Frame

Up to 2 years

Title

Determine the Area under the curve (AUC) at fixed time intervals (e.g., from Day 0 to Day 28).

Description

Assess the expansion and persistence of ECT204 T cells after infusion.

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed HCC, which is unresectable, recurrent and/or metastatic. GPC3-positive expression in HCC tumor cells by immunohistochemistry (IHC). Must have failed or not tolerated at least two (2) different anti-HCC systemic agents. Life expectancy of at least 4 months per Principal Investigator's opinion. Karnofsky Performance Scale ≥ 70. Measurable disease by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v.1.1). Previously treated lesions are allowed as long as there is a new confirmed measurable component. Child-Pugh score of A6 or better. Adequate organ function. Exclusion Criteria: Clinically significant pre-existing illness (e.g., heart failure) Active, uncontrolled systemic bacterial, fungal, or viral infection Active malignancy other than HCC, with the exception of cholangiocarcinoma (CCA) without any organ involvement and with an expected survival greater than or equal to 3 years without any treatment (exception: hormone/androgen- deprivation therapy) Currently receiving or ending (< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery. Active autoimmune disease requiring therapy Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction History of organ transplant Advanced HCC involving greater than half (50%) of the liver

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Teresa Klask, BS

Phone

925-949-9314

Teresa.Klask@eurekainc.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pei Wang, PhD

Phone

510-654-7045

Pei.Wang@eurekainc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pei Wang, PhD

Organizational Affiliation

Eureka Therapeutics Inc.

Official's Role

Study Director

Facility Information:

Facility Name

City of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claudia Aceves

Phone

626-218-5114

caceves@coh.org

First Name & Middle Initial & Last Name & Degree

Daneng Li, MD

Facility Name

Kansas University Medical Center

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Davis

Phone

913-588-0242

adavis43@kumc.edu

First Name & Middle Initial & Last Name & Degree

Raed Al-Rajabi, MD

12. IPD Sharing Statement

Learn more about this trial

ECT204 T-Cell Therapy in Adults With Advanced HCC

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