Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects
|ClinicalTrials.gov Identifier: NCT01252641|
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : June 11, 2015
This research study is being carried out to study a new way to possibly treat human immunodeficiency virus (HIV). The agent is called SB-728-T which are CD4+ T-cells obtained from an individual that are genetically modified at the CCR5 gene by Zinc Finger Nucleases. The CCR5 gene is required for certain types of HIV to enter into and infect 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 the CCR5 gene on their T-Cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 genes on their T-cells and their HIV disease is less severe and is slower to cause disease (AIDS).
The purpose of this research study is to find out whether SB-728-T is safe to give to humans and find out how this affects HIV.
|Condition or disease||Intervention/treatment||Phase|
|HIV HIV Infection||Biological: SB-728-T||Phase 1 Phase 2|
Laboratory studies have shown that when CD4+ T-cells are modified with Zinc Finger Nucleases SB-728, HIV is prevented from killing the CD4+ T-cells. On the basis of these laboratory results, there is the potential that this may work in humans infected with HIV and improve their immune system by allowing their CD4+ T-cells to survive longer.
The new treatment to be studied will involve removing white blood cells from the blood that contain CD4+ T-cells. The extracted CD4+ T-cells are then genetically modified by the Zinc finger Nucleases to be resistant to infection 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 the individual. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2, Open Label, Single Infusion Study of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases (SB-728-T) in HIV Infected Subjects|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||May 2015|
Subjects will receive one intravenous infusion of SB-728-T
Each infusion will be 5-30 billion modified CD4+ T-cells
- Evaluate the safety and tolerability of SB-728-T cells infusion in HIV-1 positive subjects [ Time Frame: 12 months ]Evaluate the safety and tolerability of a single infusion of 5-30 billion SB-728-T cells in HIV-1 positive subjects
- Evaluate persistence of HIV as measured by HIV-1 RNA, [ Time Frame: 12 months ]
- Change in CD4+ T-cell count [ Time Frame: 12 months ]
- Persistence of SB-728-T in the peripheral blood [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252641
|United States, California|
|UCLA CARE Center|
|Los Angeles, California, United States, 90035|
|Orange Coast Medical Group|
|Newport Beach, California, United States, 92663|
|Quest Clinical Research|
|San Francisco, California, United States, 94115|
|United States, Florida|
|Orlando Immunology Center|
|Orlando, Florida, United States, 32803|
|Study Director:||Winson Tang, M.D.||Sangamo BioSciences, Inc.|