Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2022-03-11
2027-12-31
Brief Summary
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Detailed Description
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The protocol describes two parts: Part 1 (dose escalation) and Part 2 (expansion).
Part 1: Dose Escalation
Part 2: Expansion
\- The initial cohort of Part 2 is defined as the "RP2D Confirmatory Cohort"
'Phase 1' is defined as Part 1 plus the initial RP2D confirmatory cohort in Part 2, and 'Phase 2' is defined as the subsequent expansion cohort in Part 2.
The protocol itself does not label phases; it uses Part 1 and Part 2 terminology only.
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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation, RP2D Confirmatory, and Expansion (Phase 1/2 Single Arm)
Dose Escalation Cohort: Patients receive a single infusion of ECT204 T cells at one of four predefined dose levels on Day 0 after conditioning. Conditioning consists of fludarabine (Flu) and cyclophosphamide (Cy).
RP2D Confirmatory Cohort: Patients receive ECT204 T cells at the RP2D on Day 0 and may receive a second infusion approximately one month later. This cohort uses the same Flu/Cy conditioning as the dose-escalation cohort; no conditioning is given before the second ECT204 infusion.
Expansion Cohort: Patients receive multiple ECT204 infusions at the RP2D (initial on Day 0, planned second on Day 31, and optional third or later doses). The third infusion may be administered no earlier than Day 60, and each subsequent infusion must be separated by at least 30 days. Patients receive Flu/Cy/regorafenib before the first infusion and regorafenib alone before the second and subsequent infusions.
ECT204 T cells
ECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.
Interventions
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ECT204 T cells
ECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.
Eligibility Criteria
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Inclusion Criteria
* GPC3-positive tumor expression confirmed by immunohistochemistry (IHC).
* For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC.
* Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+/3+ IHC.
* Must have failed, or not tolerated, at least two (2) different anti-HCC systemic agents.
* Life expectancy of at least 4 months per the Investigator's opinion.
* Karnofsky Performance Scale of 70 or higher.
* Measurable disease by RECIST v1.1.
* Child-Pugh score of A6 or better.
* Adequate organ function.
Exclusion Criteria
* Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
* Active malignancy (other than HCC), with the exception of cholangiocarcinoma (CCA) or any malignancy without any organ involvement and with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen- deprivation therapy).
* Pregnant or lactating women.
* Currently receiving or ending (\< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.
* Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
* Active autoimmune disease requiring systemic immunosuppressive therapy.
* Presence of portal vein tumor thrombus (PVTT) classified as grade Vp4, or any invasion into the inferior vena cava (IVC).
* Ascites requiring active treatment.
* History of organ transplant.
* Advanced HCC involving greater than half (50%) of the liver.
18 Years
ALL
No
Sponsors
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Eureka Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pei Wang, PhD
Role: STUDY_DIRECTOR
Eureka Therapeutics Inc.
Locations
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City of Hope
Duarte, California, United States
Kansas University Medical Center, Principal Investigator:
Westwood, Kansas, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Texas Southwestern, Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States
Fred Hutchinson Cancer Center, University of Washington
Seattle, Washington, United States
National Taiwan University Cancer Center
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ETUS20GPC3AR124
Identifier Type: -
Identifier Source: org_study_id
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