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CAR-T Cells for HIV Infection

RecruitingPhase 1/2

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

Who can join

Ages 18 to 65 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Male or female, age ≥ 18 and ≤ 65 years
* HIV-1 infection
* On continuous antiretroviral therapy for at least 12 months without any interruptions of greater than 14 consecutive days, and on a stable regimen that does not include a non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks or any long-acting ART drug that may be active in the participant after ART interruption for up to one year, without plans to modify ART during the study period
* Screening plasma HIV RNA levels below the limit of quantification on all available determinations in past 12 months (isolated single values ≥ 40 but \< 200 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations)
* CD4+ T cell count nadir \> 300 cells/mm3
* Screening CD4+ T-cell count ≥ 500 cells/mm3
* Available ART treatment history and the capacity to construct an effective antiretroviral treatment regimen
* Willing to pause ART as part of the study

Exclusion Criteria:

* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* ART regimen that includes a long-acting anti-HIV drug and/or NNRTI that may be active in the participant for up to one year after ART interruption
* ART regimen that includes protease inhibitor(s) and/or AZT. These drugs may increase the toxicity of cyclophosphamide.
* Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers
* History of or current active hepatitis B (HBV) infection defined as positive HBV surface antigen test. A positive anti-HBc regardless of HBsAg status.
* Active hepatitis C (HCV) infection
* Active or latent tuberculosis infection
* Chronic liver disease
* Active and poorly controlled atherosclerotic cardiovascular disease
* Unwillingness to abstain from sex or use barrier protection for any sexual activity during the treatment interruption.

About the study

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.

What is being tested

Sponsor: Steven Deeks · Participants: 18 · Started: Mar 1, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04648046

Locations in the U.S.

CaliforniaUniversity of California, Davis, Sacramento
Zuckerberg San Francisco General, San Francisco

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.