Ignite Creation Date:
2024-05-06 @ 8:20 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02715362
Status:
UNKNOWN
Last Update Posted:
2016-03-22
First Post:
2016-03-11
Brief Title:
A Study of GPC3 Redirected Autologous T Cells for Advanced HCC
Sponsor:
Shanghai GeneChem Co Ltd
Organization:
Shanghai GeneChem Co Ltd
Study Overview
Official Title:
An Open-label Uncontrolled Single-arm Pilot Study to Evaluate Vascular Interventional Therapy Mediated GPC3-targeted Chimeric Antigen Receptor T Cells in Advanced Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GPC3-CART
Brief Summary:
Intravenous infusion of CART cells in the treatment of solid tumors may be not a suitable choice Because by intravenous infusion T cells first entered into the blood circulation but the number of T cells accumulated at the tumor site is limited while the probability is high that CART cells contact with normal tissue where target protein is expressed leading to a more potential off-target side effect In this study CART cells infused to the body is mediated by the method of transcatheter arterial infusionTAI which is one kind of tumor intervention therapy pathway We hope by this means could improve the local CAR-T cell numbersmeanwhile reduce the potential side effects
Detailed Description:
Patients treated with leukapheresis from which peripheral blood mononuclear cells are purified T cells are activated and then re-engineered to express chimeric antigen receptors CARs specific for GPC3 Cells are expanded in culture and returned to the participant by transcatheter arterial infusion at the dose of 1-10106 CAR positive T cellskg The cells perfusion process would last for 15min to 2 h via an ambulatory infusion pump A single dose of 15 gramsm2 of cyclophosphamide will be given two days before CART cell infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None