Actively Recruiting
CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS
Led by City of Hope Medical Center · Updated on 2026-02-23
15
Participants Needed
2
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of screening
- Karnofsky Performance Status (KPS) of 70 or higher
- Documented HIV-1 infection prior to study entry
- On stable antiretroviral therapy with undetectable HIV-1 RNA (less than 20 copies/mL) for at least 48 weeks prior to screening
- Allowance for up to two plasma HIV-1 RNA blips between 25 and 200 copies/mL
- CD4+ cell count of 450 cells/µL or higher
- Adequate organ function
- Willingness to interrupt antiretroviral therapy for 4 days before leukapheresis
- Not pregnant or breastfeeding
You will not qualify if you...
- Presence of concurrent illness or comorbid condition
- History of resistance to two or more classes of antiretroviral drugs
- Previous receipt of an experimental HIV-1 immunotherapeutic agent or gene therapy product
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
UCSD, Division of Infectious Diseases and Global Public Health
San Diego, California, United States, 92093
Actively Recruiting
Research Team
M
Marvin Hanashiro
CONTACT
S
Steven Hendrickx
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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