About this trial
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 criteria
Qualifiers
patients with advanced HCC,which express GPC3 protein.
Life expectancy >12 weeks
Child-Pugh-Turcotte score <7
Adequate heart,lung,liver,kidney function
Disqualifiers
Had accepted gene therapy before;
Tumor size more than 25cm;
Severe virus infection such as HBV,HCV,HIV,et al
Known HIV positivity
Trial design
Treatments tested in this trial
- GPC3 and/or TGFβ targeting CAR-T cells
Treatment groups
Sponsors and collaborators
Second Affiliated Hospital of Guangzhou Medical University
Lead sponsor
Hunan Zhaotai Yongren Medical Innovation Co. Ltd.
Collaborator
Guangdong Zhaotai InVivo Biomedicine Co. Ltd.
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator