RecruitingPhase 1NCT03198546

GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression

CAR-T Cell Targeting GPC3 for Immunotherapy of Hepatocellular Carcinoma: Phase I Clinical Trial


Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

30 participants

Start Date

Jul 1, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

The third/fourth generation of CAR-T cells that target GPC3 (GPC3-CART cell) and/or soluble TGFβ (GPC3/TGFβ-CART )have been constructed and their anti-HCC function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test the anti-cancer function by the GPC3/TGFβ-CAR-T cells in human HCC patients with GPC3 expression. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/TGFβ-CAR-T cell immunotherapy on human will firstly be tested.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy — immune cells genetically engineered to target a protein called GPC3 — specifically for people with advanced liver cancer (hepatocellular carcinoma, or HCC) whose tumours express this protein. **You may be eligible if...** - You have been diagnosed with advanced liver cancer (HCC) and your tumour tests positive for the GPC3 protein - Your expected survival is more than 12 weeks - Your liver function score (Child-Pugh score) is below 7, meaning your liver is functioning adequately - Your heart, lungs, liver, and kidneys are functioning well enough - Lab tests confirm your modified immune cells are working effectively against GPC3-positive targets **You may NOT be eligible if...** - You have previously received gene therapy - Your tumour does not express the GPC3 protein - Your liver or other organs are too severely affected - You are pregnant or breastfeeding 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

BIOLOGICALGPC3 and/or TGFβ targeting CAR-T cells

Engineering GPC3 or/and TGFβ targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Tigit secreting vector into T cells with knockdown of PD1/HPK1, which are isolated from patients with advanced HCC, and then transfusing them back the patients.


Locations(2)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT03198546


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