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

NCT04201782 | Terminated DMC FDA Drug

• 1 other identifier: SB-728-1003
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV-1-infection

Keywords

HIV; gene editing; CCR5

Outcome Measures

Primary Outcomes (1)

• Long-term safety of treatment with SB-728-T or SB-728mR-T

  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 Outcomes (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.

  2 years

Study Arms (1)

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

Interventions

There are no disallowed treatments DRUG

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.

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Sangamo Therapeutics: lead

Study Sites (4)

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Circle CARE Center, LLC

Norwalk, Connecticut, 06850, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

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

Study Officials

• Medical Monitor

  Sangamo Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: March 18, 2011
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

US (4)