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Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects

Primary Purpose

HIV, HIV Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SB-728-T

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCLA CARE Center
Orange Coast Medical Group
Quest Clinical Research
Orlando Immunology Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SB-728-T

Arm Description

Subjects will receive one intravenous infusion of SB-728-T

Outcomes

Primary Outcome Measures

Evaluate the safety and tolerability of SB-728-T cells infusion in HIV-1 positive subjects

Evaluate the safety and tolerability of a single infusion of 5-30 billion SB-728-T cells in HIV-1 positive subjects

Secondary Outcome Measures

Evaluate persistence of HIV as measured by HIV-1 RNA,

Change in CD4+ T-cell count

Persistence of SB-728-T in the peripheral blood

Full Information

NCT ID

NCT01252641

First Posted

November 29, 2010

Last Updated

September 17, 2019

Sponsor

Sangamo Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01252641

Brief Title

Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects

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 Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sangamo Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV, HIV Infection

Keywords

HIV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SB-728-T

Arm Type

Experimental

Arm Description

Subjects will receive one intravenous infusion of SB-728-T

Intervention Type

Biological

Intervention Name(s)

SB-728-T

Intervention Description

Each infusion will be 5-30 billion modified CD4+ T-cells

Primary Outcome Measure Information:

Title

Evaluate the safety and tolerability of SB-728-T cells infusion in HIV-1 positive subjects

Description

Evaluate the safety and tolerability of a single infusion of 5-30 billion SB-728-T cells in HIV-1 positive subjects

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Evaluate persistence of HIV as measured by HIV-1 RNA,

Time Frame

12 months

Title

Change in CD4+ T-cell count

Time Frame

12 months

Title

Persistence of SB-728-T in the peripheral blood

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Winson Tang, M.D.

Organizational Affiliation

Sangamo BioSciences, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

UCLA CARE Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90035

Country

United States

Facility Name

Orange Coast Medical Group

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Quest Clinical Research

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Orlando Immunology Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects

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