Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01044654
Status:
COMPLETED
Last Update Posted:
2015-03-13
First Post:
2010-01-06
Brief Title:
Phase 1 Dose Escalation Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Patients
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
A Phase 1 Dose Escalation Single Dose Study of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-278 in HIV-Infected Patients Who Have Exhibited Suboptimal CD4 T-Cell Gains During Long-Term Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
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 research study is being carried out to study a new way to possibly treat HIV This agent is called a Zinc Finger Nuclease or ZFN for short ZFNs are proteins that can delete another protein named CCR5 This CCR5 protein is required for certain types of HIV CCR5 tropic to enter into and infect your T-cells T cells are one of the white blood cells used by the body to fight HIV The most important of these are called CD4 T-cells
Some People are born without CCR5 on their T-cells These people remain healthy and are resistant to infection with HIV Other people have a low number of CCR5 on their T-cells and their HIV disease is less severe and is slower to cause disease AIDS
Even with no detectable levels of HIV in the blood HIV remains in some tissues in the body primarily the gut tissue HIV infects the CD4 T-cells including in the blood and gut The new treatment to be studied will involve removing white blood cell from the blood that contains CD4 T-cells The extracted CD4 T-cells are then genetically modified by the ZFNs to be resistant to infection by HIV by removing the CCR5 gene from the surface of the CD4 T cell where HIV enters the cell Additional genetically modified cells are manufactured and then re-infused back into you Researchers hope that these genetically modified cells will be resistant to infection by HIV and will be able to reproduce additional resistant CD4 T-cells in your body
Laboratory studies have shown that when CD4 T-cells are modified with ZFNs HIV is prevented from killing the CD4 T-cells On the basis of these laboratory results thre is the potential that ZFNs may work in humans infected with HIV and improve their immune system by allowing their CD4 T-cells to survive longer
The purpose of this research study is to find out whether zinc finger modified CD4 T-cells are safe to give to humans and find how zinc finger modified T-cell affects HIV
Some People are born without CCR5 on their T-cells These people remain healthy and are resistant to infection with HIV Other people have a low number of CCR5 on their T-cells and their HIV disease is less severe and is slower to cause disease AIDS
Even with no detectable levels of HIV in the blood HIV remains in some tissues in the body primarily the gut tissue HIV infects the CD4 T-cells including in the blood and gut The new treatment to be studied will involve removing white blood cell from the blood that contains CD4 T-cells The extracted CD4 T-cells are then genetically modified by the ZFNs to be resistant to infection by HIV by removing the CCR5 gene from the surface of the CD4 T cell where HIV enters the cell Additional genetically modified cells are manufactured and then re-infused back into you Researchers hope that these genetically modified cells will be resistant to infection by HIV and will be able to reproduce additional resistant CD4 T-cells in your body
Laboratory studies have shown that when CD4 T-cells are modified with ZFNs HIV is prevented from killing the CD4 T-cells On the basis of these laboratory results thre is the potential that ZFNs may work in humans infected with HIV and improve their immune system by allowing their CD4 T-cells to survive longer
The purpose of this research study is to find out whether zinc finger modified CD4 T-cells are safe to give to humans and find how zinc finger modified T-cell affects HIV
Detailed Description:
None
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