Trial record 1 of 1 for:    NCT01252641
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Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sangamo Biosciences
ClinicalTrials.gov Identifier:
NCT01252641
First received: November 29, 2010
Last updated: February 20, 2014
Last verified: February 2014

November 29, 2010
February 20, 2014
November 2010
September 2013   (final data collection date for primary outcome measure)
Evaluate the safety and tolerability of SB-728-T cells infusion in HIV-1 positive subjects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Evaluate the safety and tolerability of a single infusion of 5-30 billion SB-728-T cells in HIV-1 positive subjects
Treatment related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Number of participants who report adverse events as a measure of safety and tolerability
Complete list of historical versions of study NCT01252641 on ClinicalTrials.gov Archive Site
  • Evaluate persistence of HIV as measured by HIV-1 RNA, [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Change in CD4+ T-cell count [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Persistence of SB-728-T in the peripheral blood [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • HIV Infection
Biological: SB-728-T
Each infusion will be 5-30 billion modified CD4+ T-cells
Experimental: SB-728-T
Subjects will receive one intravenous infusion of SB-728-T
Intervention: Biological: SB-728-T
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented HIV infection
  • CD4+ T-cell count >500 cell per millimeter cubed (cells/mm3)
  • CD4+ T-cell nadir of >400 cells/mm3
  • HIV viral load >1,000 copies per milliliter (mL)

Exclusion Criteria:

  • Any viral hepatitis
  • Acute HIV infection
  • HIV viral load >1,000,000 copies/mL
  • Active or recent (prior 6 months) AIDS defining complication
  • Any HIV medications within the past 12 weeks
  • Cancer or malignancy that has not been in remission for at least 5 years with the exception of successfully treated basal cell carcinoma of the skin
  • Current diagnosis of NYHA grade 3 or 4 congestive heart failure or uncontrolled angina or arrhythmias
  • History of bleeding problems
  • Use of chronic steroids in past 30 days
  • Pregnant or breast feeding
  • Active drug or alcohol abuse
  • Serious illness in past 30 days
  • Currently participating in another clinical trail or any prior gene therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01252641
SB-728-1002
No
Sangamo Biosciences
Sangamo Biosciences
Not Provided
Study Director: Winson Tang, M.D. Sangamo BioSciences, Inc.
Sangamo Biosciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP