Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04201782 |
Recruitment Status :
Enrolling by invitation
First Posted : December 17, 2019
Last Update Posted : July 29, 2021
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Condition or disease | Intervention/treatment | Phase |
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HIV-1-infection | Drug: There are no disallowed treatments | Phase 1 |
Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T and have completed 3 years of post-infusion follow-up will be eligible to participate in this trial. There will be no treatment in this long-term follow-up study. Subjects who choose to enroll into this extension study will be evaluated for a total of 12 years.
An optional leukapheresis may be performed upon sponsor request.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 55 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Long-Term Follow-up of HIV-Infected Subjects Treated With Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases (SB-728-T or SB-728mR-T) |
Actual Study Start Date : | March 18, 2011 |
Estimated Primary Completion Date : | December 31, 2033 |
Estimated Study Completion Date : | December 31, 2033 |

Arm | Intervention/treatment |
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Experimental: Cohort 1
Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial.
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Drug: There are no disallowed treatments
Genetic: SB-728-T or SB-728mR-T No study drug is administered in this study. Subjects who received SB-728-T or SB-728mR-T in a previous trial will be evaluated in this trial for long-term safety and efficacy. |
- Long-term safety of treatment with SB-728-T or SB-728mR-T [ Time Frame: 12 years ]Number of subjects with delayed adverse events associated with administration of SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases.
- Long-term persistence of SB-728-T or SB-728mR-T [ Time Frame: 2 years ]Long-term persistence of SB-728-T or SB-728mR-T will be measured by serial measurement of CCR5 gene modification.
- Change in HIV reservoirs [ Time Frame: 2 years ]Change in HIV reservoirs will be measured by serial measurement of HIV-1 RNA, HIV proviral DNA and HIV Co-receptor Tropism

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects who have, in previous Sangamo clinical trial received SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases, have completed 3 years of post-infusion follow-up, and give consent to participate in the long-term follow-up study.
Exclusion Criteria:
There are no exclusion criteria for this study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04201782
United States, California | |
Quest Clinical Research | |
San Francisco, California, United States, 94115 | |
United States, Connecticut | |
Circle CARE Center, LLC | |
Norwalk, Connecticut, United States, 06850 | |
United States, Florida | |
Orlando Immunology Center | |
Orlando, Florida, United States, 32803 | |
United States, Texas | |
Central Texas Clinical Research | |
Austin, Texas, United States, 78705 |
Study Director: | Medical Monitor | Sangamo Therapeutics, Inc. |
Responsible Party: | Sangamo Therapeutics |
ClinicalTrials.gov Identifier: | NCT04201782 |
Other Study ID Numbers: |
SB-728-1003 |
First Posted: | December 17, 2019 Key Record Dates |
Last Update Posted: | July 29, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
HIV gene editing CCR5 |