Recruiting

Phase 1

Phase 2

CAR-T CellsCAR-T Cells for HIV Infection

Sponsor:

Steven Deeks

Code:

NCT04648046

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

LVgp120duoCAR-T cells, low dose

LVgp120duoCAR-T cells, high dose

Analytic Treatment Interruption

Study Details

Brief 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.

Conditions

HIV Infections

Study ID

NCT04648046

Start date

Mar 1, 2021

Status verified date

Apr, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low Dose CAR-T Cells Only

Participants will NOT undergo non-ablative conditioning with cyclophosphamide. A single dose of 3 x 10\^5 cells/kg LVgp120duoCAR-T cells will be infused. ART will be interrupted immediately after infusion.

experimental: Conditioning + Low Dose CAR-T Cells

Participants will undergo non-ablative conditioning with cyclophosphamide. A single dose of 3 x 10\^5 cells/kg LVgp120duoCAR-T cells will be infused. ART will be interrupted immediately after infusion.

experimental: Conditioning + High Dose CAR-T Cells

Participants will undergo non-ablative conditioning with cyclophosphamide. A single dose of 1 x 10\^6 cells/kg LVgp120duoCAR-T cells will be infused into the participant. ART will be interrupted immediately after infusion.

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.

Primary outcome measure

Number of participants reporting a new Grade 3 or greater adverse event that is definitely, probably, or possibly related to study treatment within 1 year of product administration. [ Time Frame: Within 1 year of product administration ]
Number of participants achieving post-treatment control within 36 weeks of product administration. [ Time Frame: Week 36 ]

Central Contacts and Locations

Central contacts

Rebecca Hoh

415-476-4082 rebecca.hoh@ucsf.edu

Locations

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Christina Dyner, RN

cjdyer@ucdavis.edu

Principal Investigator:

Mehrdad Abedi

Zuckerberg San Francisco General

Recruiting

San Francisco, California, United States, 94110

Contacts

Rebecca Hoh, MS

415-476-4082 rebecca.hoh@ucsf.edu

Principal Investigator:

Steven Deeks, MD

More Information

Sponsor

Steven Deeks

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

HIV
HIV/AIDS
CAR-T cells
HIV cure
HIV reservoir
Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Steven Deeks on 2026-04-09.