CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06252402
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • HIV-1

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • CMV/HIV-CAR T Cells — BIOLOGICAL
    Eligible participants will temporarily interrupt their ART regimen for 4 days prior to leukapheresis to prevent residual cell drug levels that could inhibit lentiviral transduction of the T cells during CAR T cewll manufacturing. Participants will resume their ART regimen immediately after leukapheresis. Once the final cell product is released, participants will receive a single intravenous (IV)infusion of autologous CMV/HIV-CAT T cells (defined as Day 0). Up to three doses of CMV/HIV-CAR T cewlls may be explored.

Study Details

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.

Key Dates

Start date
Dec 19, 2024
Status verified
Feb 2026
Primary completion
Dec 11, 2026
Completion
Dec 11, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -1
    EGFR+ T Cell Dose (Day 0) 5 x 10\^6 cells
  • Experimental: Dose Level +1
    EGFR+ T Cell Dose (Day 0) 25 x 10\^6 cells
  • Experimental: Dose Level +2
    EGFR+ T Cell Dose (Day 0) 50 x 10\^6 cells

Primary Outcome Measure

Dose limiting toxicities (DLT) [ Time Frame: Up to 28 days after the infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
John H. Baird, MD (PRINCIPAL_INVESTIGATOR)
UCSD, Division of Infectious Diseases and Global Public HealthSan DiegoCalifornia92093
David Smith, MD
David Smith, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAUCSD, Division of Infectious Diseases and Global Public Health· San Diego, CA

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