Clinical Trials

MainTitle

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

This study has been enrolling by invitation
Sponsor
Sangamo Therapeutics


Information provided by (Responsible Party)
Sangamo Therapeutics
ClinicalTrials.gov Identifier
NCT04201782

First received: December 13, 2019
Last updated: July 15, 2020
Last Verified: October 2019
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV-1-infection

Drug : There are no disallowed treatments
Phase 1

Study Type: Interventional
Study Design: 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)

Further study details as provided by Sangamo Therapeutics:

Primary Outcome Measures

  • 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:
  • 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:
  • 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

Estimated Enrollment: 55
Study Start Date: March 18, 2011
Estimated Study Completion Date: December 31, 2031
Estimated Primary Completion Date: December 31, 2031 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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.

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04201782

Locations

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, New Mexico
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705

Sponsors and Collaborators

Sangamo Therapeutics

Investigators

Study Director: Medical Monitor Sangamo Therapeutics, Inc.
More Information

More Information


Responsible Party: Sangamo Therapeutics  
ClinicalTrials.gov Identifier: NCT04201782   History of Changes  
Other Study ID Numbers: SB-728-1003  
Study First Received: December 13, 2019  
Last Updated: July 15, 2020  

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

ClinicalTrials.gov processed this data on August 07, 2020
This information is provided by ClinicalTrials.gov.