Using CAR-T cells to treat 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
PHASE1; PHASE2 · University of California, San Francisco · NCT04648046
This study is testing a new treatment using modified immune cells to see if it can help people with HIV by targeting and potentially eliminating the virus in their bodies.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Drugs / interventions | cyclophosphamide |
| Locations | 2 sites (Sacramento, California and 1 other locations) |
| Trial ID | NCT04648046 on ClinicalTrials.gov |
What this trial studies
This is a limited-center, open-label dose escalating study that evaluates the safety and efficacy of autologous T cells expressing LVgp120duoCAR molecules in individuals with HIV infection. Participants will be enrolled in three cohorts, with each cohort receiving different doses of CAR-T cells following a 3+3 design. The study will assess safety over a 45-day period before proceeding to higher doses, and participants will temporarily pause their HIV medications during the treatment. The goal is to determine the potential of this innovative therapy to target and eliminate HIV reservoirs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with HIV-1 infection who have been on stable antiretroviral therapy for at least 12 months.
Not a fit: Patients with uncontrolled HIV, recent interruptions in ART, or those with certain comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a functional cure for HIV, reducing the need for lifelong antiretroviral therapy.
How similar studies have performed: While CAR-T cell therapy has shown promise in other conditions, this specific application for HIV is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sacramento, California and 1 other locations
- University of California, Davis — Sacramento, California, United States (RECRUITING)
- Zuckerberg San Francisco General — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Steven Deeks, MD — University of California, San Francisco
- Study coordinator: Rebecca Hoh
- Email: rebecca.hoh@ucsf.edu
- Phone: 415-476-4082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV Infections, HIV, HIV/AIDS, CAR-T cells, HIV cure, HIV reservoir, Immunotherapy