CAR-T Cell Immunotherapy for HCC Targeting GPC3
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02723942|
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : August 16, 2017
|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 :||60 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, 2017|
|Actual Study Completion Date :||August 15, 2017|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|