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
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• HIV-1-infection

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