NCT03666871

CCR5-modified CD4+ T Cells for HIV Infection

T-Cell Reinfusion After Interfering With Lymphocyte Binding Location of AIDS Virus Through Zinc-finger-nuclease Elimination of CCR5 Receptors: The TRAILBLAZER Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Comparative Study of Autologous CD4+ T Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 versus ex vivo Expanded Unmodified Autologous CD4+ T Cells in Treated HIV-1 Infected Subjects

Detailed description

This is a randomized clinical trial comparing the effect of infusing expanded autologous CD4+ T cells with or without ex vivo modification of the CCR5 gene by zinc finger nucleases among HIV-infected patients with plasma HIV RNA levels \<50 copies/mL for at least 48 weeks and CD4+ T cell counts greater than 350 cells/µL. The main hypothesis is that the infusion of modified CD4+ T cells will lead to a reduction in the size of the replication-competent HIV reservoir, that is greater than that resulting from infusion of unmodified CD4+ T cells. A total of 30 participants will be randomized to receive one infusion of 0.5 - 4 x 1010 ex vivo expanded autologous CD4+ T cells that have been either modified by transduction with a zinc finger nuclease designed to cleave CCR5 (arm 1, n=20) or unmodified (arm 2, n=10). All participants will be pre-treated with cyclophosphamide at a dose of 1 g/m2 before infusion. The primary outcome measure the difference in the magnitude of change in intact provirus from before infusion to 96 weeks after infusion between the two study arms.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	SB-728-T	Autologous CD4+ T cells with ex vivo modification of the CCR5 gene by zinc finger nucleases
BIOLOGICAL	Expanded unmodified autologous CD4+ T cells	Autologous CD4+ T cells without ex vivo modification of the CCR5 gene by zinc finger nucleases

Timeline

• Start date: 2019-06-12
• Primary completion: 2024-01-31
• Completion: 2024-02-28
• First posted: 2018-09-12
• Last updated: 2024-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study