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There have been no significant safety issues in any subjects exposed between 7.5 and 13.5 years ago to either SB-728-T or SB-728mR-T, including no delayed adverse events related to the investigational product.
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Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T. Enrolling subjects will be followed for a total of 12 years.
Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There are no disallowed treatments | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety of treatment with SB-728-T or SB-728mR-T | Number of subjects with SAEs. 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. Incidence of new malignancies, neurologic disorders (new or exacerbation of pre-existing), rheumatologic disease (new or exacerbation of pre-existing), autoimmune disorder (new or pre-existing), and new hematologic disorder. | 12 years |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term effects of SB-728-T or SB-728mR-T on CD4+ T-cell counts and on the viral load and tropism of HIV in blood. | Long-term effects of SB-728-T or SB-728mR-T will be measured by the following: CD4+ T-cell counts through Month 24 HIV co-receptor tropism through Month 24 Viral load through Month 24 | 2 years |
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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 and give consent to participate in the long-term follow-up study.
Exclusion Criteria:
There are no exclusion criteria for this study.
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HIV-Infected Subjects who received SB-728-T under BB-IND 14129 or SB-728mR-T under BB-IND 16082.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sangamo Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quest Clinical Research | San Francisco | California | 94115 | United States | ||
| Circle CARE Center, LLC |
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| Norwalk |
| Connecticut |
| 06850 |
| United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |