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

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
Sponsor:
Information provided by (Responsible Party):
Sangamo Therapeutics

Study Description
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Brief Summary:
Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial and completed 3 years of post-infusion follow-up. Enrolling subjects will be followed for a total of 12 years.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: There are no disallowed treatments Phase 1

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Sangamo Therapeutics
Investigators
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Study Director: Medical Monitor Sangamo Therapeutics, Inc.
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sangamo Therapeutics:
HIV
gene editing
CCR5