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

Who is this study for? Adults with Hepatocellular Carcinoma
What treatments are being studied? GPC3 and/or TGF? Targeting CAR-T cells
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• patients with advanced HCC,which express GPC3 protein.

• Life expectancy \>12 weeks

• Child-Pugh-Turcotte score \<7

• Adequate heart,lung,liver,kidney function

• 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

• Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -

Locations
Other Locations
China
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Zhenfeng Zhang, MD,PhD
zhangzhf@gzhmu.edu.cn
0086-020-34153532
Backup
Peng Li, PhD
lipeng@invivobio.com.cn
+86 20 32015300
Time Frame
Start Date: 2017-07-01
Estimated Completion Date: 2036-08-01
Participants
Target number of participants: 30
Treatments
Other: CAR-T cell therapy group
Appropriate patients who could benefit from the GPC3 and TGFβ targeting CAR-T cell therapy against HCC are chosen to be the CAR-T cell therapy group.
Related Therapeutic Areas
Lung Cancer
Liver Cancer
Sponsors
Leads: Second Affiliated Hospital of Guangzhou Medical University
Collaborators: Guangdong Zhaotai InVivo Biomedicine Co. Ltd., First Affiliated Hospital, Sun Yat-Sen University, Hunan Zhaotai Yongren Medical Innovation Co. Ltd.

This content was sourced from clinicaltrials.gov

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