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NCT01252641 · ClinicalTrials.gov registry record · Phase 1
Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects
A Phase 1 study, sponsored by Sangamo Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01252641: Completed Phase 1 study, sponsored by Sangamo Therapeutics.
NCT01252641 is a Phase 1 study that has completed, run by Sangamo Therapeutics. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01252641, a Phase 1 study, has completed, sponsored by Sangamo Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
Evaluate the safety and tolerability of a single infusion of 5-30 billion SB-728-T cells in HIV-1 positive subjects
Interventions
- BIOLOGICAL SB-728-T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT01252641 record still lists
NCT01252641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which SB-728-T is the first listed.
NCT01252641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01252641 about?
NCT01252641 is a clinical study titled "Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases 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 cer...
What is the current status of trial NCT01252641?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-11. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01252641?
The interventions under investigation include: SB-728-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT01252641?
This trial is sponsored by Sangamo Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01252641's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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