HIVPhase 1/2NCT01252641
Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects
A Phase 1/2 study testing SB-728-T in people with HIV and HIV Infection, run by Sangamo Therapeutics at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infection
- What is being tested?
- SB-728-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2010to May 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UCLA CARE Center
Los Angeles, California, 90035
Orange Coast Medical Group
Newport Beach, California, 92663
Orlando Immunology Center
Orlando, Florida, 32803
Quest Clinical Research
San Francisco, California, 94115
About this study
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
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.
Read the 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.
- Conditions
- HIV, HIV Infection
- Being tested
- SB-728-T
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-728-TBiological
Each infusion will be 5-30 billion modified CD4+ T-cells
| Study group | Role | What they receive |
|---|---|---|
| SB-728-T | Experimental | Subjects will receive one intravenous infusion of SB-728-T Receives: Biological: SB-728-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
Evaluate persistence of HIV as measured by HIV-1 RNA,
Measured: 12 months
Change in CD4+ T-cell count
Measured: 12 months
Persistence of SB-728-T in the peripheral blood
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sangamo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Winson Tang, M.D., Study director, Sangamo BioSciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252641
- Sponsor's protocol ID
- SB-728-1002
- Status last verified
- Sep 2019
- First submitted
- 29 Nov 2010
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01252641
- Acronym / sponsor ID
- SB-728-1002
- Conditions
- HIV, HIV Infection
- Keywords
- HIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sangamo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB-728-T | Experimental | Biological: SB-728-TSubjects will receive one intravenous infusion of SB-728-T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB-728-TEach infusion will be 5-30 billion modified CD4+ T-cells | Biological | SB-728-T |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winson Tang, M.D. study director
Sangamo BioSciences, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SB-728-T in people with HIV and HIV Infection, run by Sangamo Therapeutics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of SB-728-T cells infusion in HIV-1 positive subjects (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.