Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T

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)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04201782

Enrollment

Registered

2019-12-17

Start date

2011-03-18

Completion date

2023-07-17

Last updated

2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

Keywords

HIV, gene editing, CCR5

Brief summary

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.

Detailed description

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.

Interventions

DRUGThere 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Long-term safety of treatment with SB-728-T or SB-728mR-T	12 years	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.

Secondary

Measure	Time frame	Description
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.	2 years	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026