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

RecruitingPhase 1Ages 18 Years - 75 YearsAllSecond Affiliated Hospital of Guangzhou Medical U…
NCT03198546 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. patients with advanced HCC,which express GPC3 protein. 2. Life expectancy \>12 weeks 3. Child-Pugh-Turcotte score \<7 4. Adequate heart,lung,liver,kidney function 5. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3 CAR determined by flow-cytometry and killing of GPC3-positive targets greater than or equal to 20% in cytotoxicity assay 6. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. - Exclusion Criteria: 1. Had accepted gene therapy before; 2. Tumor size more than 25cm; 3. Severe virus infection such as HBV,HCV,HIV,et al 4. Known HIV positivity 5. History of liver transplantation 6. Active infectious disease related to bacteria, virus,fungi,et al 7. Other severe diseases that the investigators consider not appropriate; 8. Pregnant or lactating women 9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day) 10. Other conditions that the investigators consider not appropriate. -
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What it tests

  • GPC3 and/or TGFβ targeting CAR-T cells
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Where

2 sites
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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