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.
patients with advanced HCC,which express GPC3 protein.
Life expectancy >12 weeks
Child-Pugh-Turcotte score <7
Adequate heart,lung,liver,kidney function
Had accepted gene therapy before;
Tumor size more than 25cm;
Severe virus infection such as HBV,HCV,HIV,et al
Known HIV positivity
Single group
GPC3 and/or TGFβ targeting CAR-T cells
Biological/VaccineEngineering 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.
Number of Patients with Dose Limiting Toxicity
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3-T2-CAR T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
Percent of Patients with best response as either complete remission or partial remission.
Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.
Median CAR-T cell persistence
Median CAR-T cell persistence will be measured by quantitative rt-PCR.
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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
