NCT06252402RecruitingEarly phase 1
CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS
A Pilot Study to Evaluate the Feasibility and Safety of Cytomegalovirus-Specific, Anti-HIV Chimeric Antigen Receptor (CMV-HIV CAR) T Cells in People Living With HIV
Source: ClinicalTrials.gov · Last updated 23 Feb 2026
Brief summary (registry, in English)
Human immunodeficiency virus type 1 (HIV-1) causes a persistent infection that ultimately leads to acquired immunodeficiency syndrome (AIDS). Treatment of HIV-1 infection with combination anti-retroviral therapy (ART) suppresses HIV-1 replication to undetectable viral levels and saves lives. Nevertheless, ART cannot eradicate latent cellular reservoirs of the virus, and HIV-1 infection remains a life-long battle. Adoptive cellular immunotherapy using chimeric antigen receptor (CAR) engineered T cells directed against HIV-1 envelope subunit protein gp120 (HIVCAR T cells) may provide a safe and effective way to eliminate HIV-infected cells. However, the number of HIV-infected cells is low in participants under ART, and CAR T cells disappear if they are not stimulated by their target antigens. Interestingly, about 95% of HIV-1-infected individuals are CMV-seropositive and CMV-specific T cells have been shown to persist. To overcome the CAR T cells low persistence issue, we propose to make HIV-CAR T cells using autologous cytomegalovirus (CMV)-specific T cells, which can be stimulated by endogenous CMV in vivo. The overall hypothesis of this first-in-human Phase 1, open-label, single-arm study is that endogenous immune signals to CMV-specific T cells can maintain the presence of autologous bispecific CMV/HIV-CAR T cells in healthy people living with HIV-1 (PLWH), and achieve long-term remission in the presence of ART.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 1 Feb 2024
- Start date
- 19 Dec 2024
- Primary completion date
- 11 Dec 2026
- Lead sponsor
- City of Hope Medical Center
- Diseases
- HIV
- NCT number
- NCT06252402
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 15
- From 19 Dec 2024 to the primary completion date, 11 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent illness or comorbid condition;
- History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.
Other illness
- History of resistance to two or more classes of antiretroviral drugs;
Who the study is looking for
- Participant must be ≥ 18 years of age at the time of screening;
- Karnofsky Performance Status (KPS) ≥ 70;
- Documented HIV-1 infection anytime prior to study entry.;
- On stable ART with undetectable HIV-1 RNA (i.e \< 20 copies /mL) for at least 48 weeks prior to screening (2 plasma HIV-1 RNA blips 25-200 copies/mL are allowable);
- CD4+ cell count ≥ 450 cells/μL;
- Adequate organ function;
- Willingness to interrupt ART regimen for 4 days prior to leukapheresis;
- Not pregnant or breastfeeding.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| UCSD, Division of Infectious Diseases and Global Public Health Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.