RecruitingPhase 1NCT05783570

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307

A Dose-escalation, Single-arm, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 Targeted Chimeric Antigen Receptor T Cell Therapy in Patients With GPC3 Positive Advanced Hepatocellular Carcinoma Who Have Failed Standard Therapy


Sponsor

Eutilex

Enrollment

12 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 (GPC3) Targeted Chimeric Antigen Receptor T cell therapy in Patients with GPC3 Positive Advanced Hepatocellular Carcinoma who Have Failed Standard Therapy


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called EU307 for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that has not responded to previous treatments. EU307 is designed to target a protein called GPC3, which is overexpressed on certain liver cancer cells. The study is examining safety, tolerability, and early signs of effectiveness. **You may be eligible if:** - You are 19 years old or older - You have unresectable (inoperable) liver cancer confirmed by biopsy or imaging - Your cancer has progressed after or was not responsive to first- or second-line standard treatments (such as atezolizumab + bevacizumab, sorafenib, or lenvatinib) - Your tumor tests positive for the GPC3 protein - You have at least one measurable tumor that can be tracked **You may NOT be eligible if:** - Your cancer does not express the GPC3 protein - You have no standard treatment options available and your health cannot support experimental therapy - Your organ function or performance status is too poor for treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEU307 CAR-T Cell

* Dose to be administered: a single dose * IV administration * Dosing rate: To be administrated at a rate of approximately 2 mL/min


Locations(4)

Severance Hospital

Seoul, South Korea

SoonChunHyang University Hospital Seoul

Seoul, South Korea

The Catholic University of Korea Seoul ST.MARY'S Hospital.

Seoul, South Korea

National Cancer Center

Gyeonggi-do, South Korea

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NCT05783570


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