Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-04 @ 3:30 AM
Study NCT ID:
NCT02862704
Status:
UNKNOWN
Last Update Posted:
2016-08-11
First Post:
2016-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MG7 Redirected Autologous T Cells for Advanced MG7 Positive Liver Metastases(MG7-CART)
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
An Open-label, Uncontrolled, Single-arm Pilot Study to Evaluate Safety and Efficacy of Intratumoral Delivery Mediated MG7-targeted Chimeric Antigen Receptor T Cells in Advanced MG7 Positive Liver Metastases
Status:
UNKNOWN
Status Verified Date:
2016-08
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:
None
Brief Summary:
The purpose of this study is to collect the data on the safety and potential effectiveness of intra-tumor injection of MG7-CART cells under ultrasound guidance in patients with liver metastases expressing MG7 positively.
Detailed Description:
Designer T cells are prepared by PBMC which from patients by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs) specific for MG7, which is a glycosylated protein of CEA. Cells are expanded in culture and returned to the participant by intra-tumor injection at the dose of (1-6)×108 CAR positive T cells. The cells perfusion process would last for 1min to 2min. The dose of 1.5 grams/m2 of cyclophosphamide will be given two days before CART cell infusion.
Study Oversight
Has Oversight DMC:
False
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?: