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NCT04201782 Clinical Trial

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

HIV-1-infection Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04201782
Other study ID # SB-728-1003
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 18, 2011
Est. completion date July 17, 2023

Study information
Verified date January 2024
Source Sangamo Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 38
Est. completion date July 17, 2023
Est. primary completion date July 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Central Texas Clinical Research Austin Texas
United States Circle CARE Center, LLC Norwalk Connecticut
United States Orlando Immunology Center Orlando Florida
United States Quest Clinical Research San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Sangamo Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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. 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
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