Actively Recruiting
CAR-T Cells for HIV Infection
Led by Steven Deeks · Updated on 2026-04-09
18
Participants Needed
2
Research Sites
461 weeks
Total Duration
On this page
Sponsors
S
Steven Deeks
Lead Sponsor
C
Caring Cross
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CAR-T Cells for HIV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 2 18 and 2 65 years
- Diagnosed with HIV-1 infection
- On continuous antiretroviral therapy for at least 12 months without interruptions longer than 14 days
- On a stable ART regimen that does not include a non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks and no long-acting ART drug active after interruption
- Screening plasma HIV RNA levels below quantification limit in past 12 months, with allowed isolated low-level blips
- CD4+ T cell count nadir above 300 cells/mm3
- Screening CD4+ T-cell count 500 cells/mm3 or higher
- Have available ART treatment history and capacity to construct effective ART regimen
- Willing to pause ART as part of the study
You will not qualify if you...
- Pregnant, breastfeeding, or unwilling to practice birth control during the study
- ART regimen includes long-acting anti-HIV drug or NNRTI active up to one year after interruption
- ART regimen includes protease inhibitors or AZT due to increased cyclophosphamide toxicity
- History of HIV-associated malignancies or virus-related cancers
- History or current active hepatitis B infection or positive anti-HBc
- Active hepatitis C infection
- Active or latent tuberculosis infection
- Chronic liver disease
- Active and poorly controlled atherosclerotic cardiovascular disease
- Unwilling to abstain from sex or use barrier protection during treatment interruption
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
2
Zuckerberg San Francisco General
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
R
Rebecca Hoh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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