Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864054
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2021-04-14
Brief Title:
T-Cell Therapy ECT204 in Adults With Advanced HCC
Sponsor:
Eureka Therapeutics Inc
Organization:
Eureka Therapeutics Inc
Study Overview
Official Title:
An Open-Label Dose Escalation Multi-Center Phase III Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma HCC ARYA-3
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARYA-3
Brief Summary:
This is an open-label dose escalation multi-center Phase III clinical trial aimed at assessing the safety and preliminary efficacy of an investigational ARTEMIS ECT204 T-cell therapy The trial is suitable for adult subjects 18 years of age diagnosed with GPC3-positive HCC who have failed or not tolerated at least two 2 different anti-HCC systemic agents
Phase I has concluded and a Recommended Phase II Dose RP2D has been determined We are now conducting Phase II to further confirm the safety profile of ECT204 and evaluate its efficacy
Phase I has concluded and a Recommended Phase II Dose RP2D has been determined We are now conducting Phase II to further confirm the safety profile of ECT204 and evaluate its efficacy
Detailed Description:
This is an open-label dose escalation multi-center Phase III clinical trial The purpose of this study is to evaluate an investigational ARTEMIS ECT204 T-cell therapy in adult patients with GPC3-positive advanced hepatocellular carcinoma HCC In this study a patients T cells are collected and genetically modified to express Eurekas proprietary anti-GPC3 ARTEMIS T cell receptors AbTCR These modified T cells are then reintroduced into the patient to specifically seek out and destroy GPC3-expressing cancer cells
Phase 1 Dose Escalation Phase Completed RP2D of ECT204 was determined
Phase 2 Expansion Phase The expansion phase includes 2 study arms
Arm A Subjects will receive ECT204 as monotherapy
Arm B Subjects will receive pre-treatment with regorafenib STIVARGA before ECT204 administration
The active assessment period of the study will continue for 2 years Subjects will be followed for assessment of treatment safety and overall survival during Long Term Follow-Up LTFU year 2 -15
Phase 1 Dose Escalation Phase Completed RP2D of ECT204 was determined
Phase 2 Expansion Phase The expansion phase includes 2 study arms
Arm A Subjects will receive ECT204 as monotherapy
Arm B Subjects will receive pre-treatment with regorafenib STIVARGA before ECT204 administration
The active assessment period of the study will continue for 2 years Subjects will be followed for assessment of treatment safety and overall survival during Long Term Follow-Up LTFU year 2 -15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None