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RecruitingAccepts healthy volunteersEarly Phase 1

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

City of Hope Medical Center · NCT06252402

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
15
US sites recruiting
2
Study start
December 19, 2024
Record last updated
February 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: CMV/HIV-CAR T Cells

Conditions: HIV-1

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Concurrent illness or comorbid condition;
  • History of resistance to two or more classes of antiretroviral drugs;
  • History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.

Recruiting US locations

  • City of Hope Medical Center

    Duarte, CA 91010

    Site contact: John H. Baird, MD

  • UCSD, Division of Infectious Diseases and Global Public Health

    San Diego, CA 92093

    Site contact: David Smith, MD

Study contacts (from the official record)

  • Marvin Hanashiro · (619) 543-3740 · mhanashiro@health.ucsd.edu
  • Steven Hendrickx · (619) 543-6968 · smhendrickx@health.ucsd.edu
All healthy volunteers studies in California →
CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS (NCT06252402) | Bored Studies