Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04153799
Status:
UNKNOWN
Last Update Posted:
2020-05-12
First Post:
2019-10-09
Brief Title:
Study of CXCR5 Modified EGFE Chimeric Antigen Receptor Autologous T Cells in EGFR- Positive Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Single-arm Open-label Phase I Study to Evaluate the Safety and Efficacy of CXCR5 Modified EGFR Chimeric Antigen Receptor Autologous T Cells in EGFR-positive Patients With Advanced Non-small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2020-05
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:
This study is a clinical study on the safety efficacy and I phase of single center single arm open-dose climbing intravenous infusion of Anti- Epidermal growth factor receptorEGFR Chimeric Antigen ReceptorCAR T cells modified by C-X-C Chemokine receptor type 5CXCR 5 in patients with advanced adult non-small cell lung cancerNSCLC
Detailed Description:
In this study the dosenumber of cells by body weight and time of infusion should be recorded in detail according to the dosage of slope climbing and single infusion The safety of chimeric antigen receptor TCAR-T cells treatment was evaluated by observing the adverse events after cell therapy The effectiveness of CAR-T treatment was initially assessed compared with the results of the patients own previous standard treatment plan Blood was collected before and within 12 months after infusion to detect the number and activity of CAR-T cells and evaluate the pharmacokinetic characteristics of CAR-T cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None