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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 : April 13, 2023
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. Enrolling subjects will be followed for a total of 12 years.

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

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 Design
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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : June 30, 2035
Estimated Study Completion Date : June 30, 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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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.


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 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 Outcome Measures :
  1. 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



Biospecimen Retention:   None Retained
  1. Clinical condition assessment
  2. Chemistry which includes bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), sodium, potassium, chloride, bicarbonate, urea nitrogen, creatinine, total protein, albumin, calcium, and phosphorous.
  3. CBC which includes hemoglobin, hematocrit, platelet count, red cell count, and white cell count with differential count
  4. CD4+ T-cell count
  5. HIV-1 RNA
  6. HIV proviral DNA
  7. Pentamer
  8. Ad5 and SB-728-T immunogenicity
  9. Research blood

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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 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: April 13, 2023
Last Verified: April 2023

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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