Recruiting
Early Phase 1

HIV-CAR T Cells

Sponsor:

City of Hope Medical Center

Code:

NCT06252402

Conditions

HIV-1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

CMV/HIV-CAR T Cells

Study Details

Brief summary:

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

HIV-1

Study ID

NCT06252402

Start date

Dec 19, 2024

Status verified date

Feb, 2026

Completion date

Dec 11, 2026

Anticipated

Primary completion date

Dec 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

CMV/HIV-CAR T Cells

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Marvin Hanashiro

(619) 543-3740mhanashiro@health.ucsd.edu

Steven Hendrickx

(619) 543-6968smhendrickx@health.ucsd.edu

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

John H. Baird, MD

UCSD, Division of Infectious Diseases and Global Public Health

Recruiting

San Diego, California, United States, 92093

Principal Investigator:

David Smith, MD

More Information

Sponsor

City of Hope Medical Center

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • HIV-1, PLWH (Healthy People Living with HIV-1) autologus
  • CMV-specific T cells, anti-retroviral therapy (ART), Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-02-23.