CAR-T Cell Immunotherapy for HCC Targeting GPC3
|ClinicalTrials.gov Identifier: NCT02723942|
Recruitment Status : Withdrawn (Project terminated due to revision of local regulations)
First Posted : March 31, 2016
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|GPC3 Positive Hepatocellular Carcinoma CAR-T Cell Immunotherapy||Biological: CAR-T cell immunotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chimeric Antigen Receptor-Modified T Cell (CAR-T) Immunotherapy for Hepatocellular Carcinoma (HCC) Targeting Glypican-3 (GPC3)|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||August 15, 2016|
|Actual Study Completion Date :||August 15, 2016|
Experimental: CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen by infusion.
Biological: CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen.
No Intervention: no intervention
- Radiological assessment [ Time Frame: 3 months ]Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.
- The safety of CAR-T cell immunotherapy (adverse events) [ Time Frame: 4 weeks ]After CAR-T cell infusion,we will observe the potential adverse events related to the T-cell infusion such as high fever,jaundice, kidney failure and so on.
- Peripheral blood tumor markers [ Time Frame: 3 months ]tested regularly to reflect the role of the Chimeric Antigen Receptor-Modified T Cell in the removal of residual tumor cells.
- CAR-T cell testing [ Time Frame: 3 months ]The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723942
|Central laboratory in Fuda cancer hospital|
|Guangzhou, Guangdong, China, 510000|
|Study Chair:||Lizhi Niu, PhD||Fuda Cancer Hospital|