GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC

Part of paid clinical trials in Duarte, California.

Sponsor
Eureka Therapeutics Inc.
Study ID
NCT04864054
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This is an open-label, multi-center, Phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of ECT204, an investigational ARTEMIS® T-cell therapy, in adult subjects with GPC3-positive hepatocellular carcinoma (HCC) who have experienced disease progression on, or intolerance to, prior systemic therapy.

Key Dates

Start date
Mar 11, 2022
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm)
    Dose Escalation Cohort: Participants receive a single infusion of ECT204 at one of four predefined dose levels on Day 0 (completed). RP2D Confirmatory Cohort: Participants receive ECT204 at the RP2D on Day 0 and may receive a second infusion approximately one month later. Expansion Cohort: Participants receive multiple infusions of ECT204 at the RP2D, beginning on Day 0, with subsequent infusions administered according to the protocol-defined schedule.

Primary Outcome Measure

To assess the safety and tolerability of ECT204. [ Time Frame: Up to 2 years (active assessment period); additional long-term follow-up (LTFU) up to 15 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Kimberley Le, RN, MSN
[email protected]
626-218-2997
Daneng Li, MD (PRINCIPAL_INVESTIGATOR)
Kansas University Medical Center, Principal Investigator:WestwoodKansas66205-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Montefiore Einstein Comprehensive Cancer CenterThe BronxNew York10467
Molly McHugh
[email protected]
718-920-7426
R. Alejandro Sica, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Sciences UniversityPortlandOregon97239
Fatema Fareh
[email protected]
503-418-0345
Richard Maziarz, MD (PRINCIPAL_INVESTIGATOR)
Adel Kardosh, MD (SUB_INVESTIGATOR)
University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer CenterDallasTexas75235
Amala Poulose
[email protected]
David Hsieh, MD (PRINCIPAL_INVESTIGATOR)
Farrukh Awan, MD (SUB_INVESTIGATOR)
Fred Hutchinson Cancer Center, University of WashingtonSeattleWashington98109
Shelby Colden
[email protected]
206-667-5134
William Harris, MD (PRINCIPAL_INVESTIGATOR)

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City of Hope· Duarte, CAKansas University Medical Center, Principal Investigator· Westwood, KSRoswell Park Comprehensive Cancer Center· Buffalo, NYMontefiore Einstein Comprehensive Cancer Center· The Bronx, NYOregon Health and Sciences University· Portland, ORUniversity of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center· Dallas, TX

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