CAR-T Cells for HIV Infection
Recruiting · NCT04648046 · Interventional (participants receive a specific treatment) · Lead sponsor: Steven Deeks
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
2 locations listed across 1 US state.
- University of California, Davis - Sacramento, California, United States
- Zuckerberg San Francisco General - San Francisco, California, United States