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

January 25, 2024 updated by: Sangamo Therapeutics

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Circle CARE Center, LLC
    • Florida
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HIV-Infected Subjects who received SB-728-T under BB-IND 14129 or SB-728mR-T under BB-IND 16082.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sangamo Therapeutics

Investigators

  • Study Director: Medical Monitor, Sangamo Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2011

Primary Completion (Actual)

July 17, 2023

Study Completion (Actual)

July 17, 2023

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 13, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SB-728-1003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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