A Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
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|ClinicalTrials.gov Identifier: NCT02959151|
Recruitment Status : Unknown
Verified November 2016 by Shanghai GeneChem Co., Ltd..
Recruitment status was: Recruiting
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular Pancreatic Cancer Metastatic Colorectal Cancer Metastatic||Drug: CAR-T cell||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm Pilot Clinical Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: CAR-T for liver cancer
A single dose of CART cells will be administered by vascular interventional therapy or by intra-tumor injection with a dose of （1.25~4）×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused. And an interventional radiologist would operate the cell infusion.
Drug: CAR-T cell
CAR-T cells are generated by T cells from the patients or a suitable donor transfected by CAR-lentivirus vectors. There are three options for CAR-targets: GPC3 for hepatocellular carcinoma;mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic.
Other Name: chimeric antigen receptor T cells
- Number of patients with adverse event [ Time Frame: 6 weeks ]adverse event is evaluated with CTCAE, version 4.0
- Number of patients with tumor response [ Time Frame: 8 weeks ]summarize tumor response by overall response rates
- Detection of transferred T cells in the circulation using quantitative -PCR [ Time Frame: 8 weeks ]
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): NCT02959151
|Contact: Wentao Li, doctor||+86 firstname.lastname@example.org|
|Contact: Xuejun Yu, master||+86 email@example.com|
|Principal Investigator:||Wentao Li, doctor||Fudan University|