RecruitingPhase 1Phase 2NCT04648046

CAR-T Cells for HIV Infection

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

Sponsor

Steven Deeks

Enrollment

18 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

HIV Infections

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a special type of engineered immune cell therapy (CAR-T cells) designed to help the immune system control HIV. Participants will temporarily pause their regular HIV medication to see if the CAR-T cells can keep the virus suppressed on their own. **You may be eligible if...** - You are 18–65 years old with HIV-1 infection - You have been on continuous antiretroviral therapy (ART) for at least 12 months - Your HIV viral load has been undetectable for the past 12 months - Your CD4 T-cell count is at least 500 cells/mm³ - You are willing to temporarily pause your HIV medications as part of the study **You may NOT be eligible if...** - You are pregnant, breastfeeding, or unwilling to use contraception - You have a history of HIV-related cancer (such as Kaposi's sarcoma or lymphoma) - You have active hepatitis B or C, tuberculosis, or chronic liver disease - Your ART regimen includes certain drugs (long-acting antiretrovirals, NNRTIs, protease inhibitors, or AZT) - You have poorly controlled cardiovascular disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.