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CAR-T Cells for HIV Infection
Sponsor: Steven Deeks
Summary
This is a limited-center, open-label dose escalating phase I/IIa study of autologous T cells expressing LVgp120duoCAR molecules in people with HIV infection. It will follow a 3+3 design. Dose escalation decisions will be made when a minimum of three participants have completed the safety-evaluation period (45 days) at a given dose level. Cohort 1 will undergo infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 2 will undergo non-ablative conditioning with cyclophosphamide, followed by infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 3 will undergo non-ablative conditioning with cyclophosphamide, followed infusion of a single high-dose regimen of LVgp120duoCAR-T cells. Following administration of the experimental therapy, HIV medications will be paused for participants in each group during an analytic treatment interruption.
Official title: Safety and Anti-HIV Activity of Autologous CD4+ and CD8+ T Cells Transduced With a Lentiviral Vector Encoding Bi-specific Anti-gp120 CAR Molecules (LVgp120duoCAR-T) in Anti-retroviral Drug-treated HIV-1 Infection
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2021-03-01
Completion Date
2029-12-31
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Cyclophosphamide
Non-ablative conditioning with cyclophosphamide.
LVgp120duoCAR-T cells, low dose
A single dose of 3 x 10\^5 cells/kg LVgp120duoCAR-T cells will be infused.
LVgp120duoCAR-T cells, high dose
A single dose of 1 x 10\^6 cells/kg LVgp120duoCAR-T cells will be infused.
Analytic Treatment Interruption
HIV antiretroviral therapy medications will be paused.
Locations (2)
University of California, Davis
Sacramento, California, United States
Zuckerberg San Francisco General
San Francisco, California, United States