Using CMV-specific T cells to treat 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

This study is testing a new treatment using specially designed T cells to see if they can help people with HIV live better while they are on their regular medication.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: City of Hope Medical Center (other)
• Drugs / interventions: CAR T, chimeric antigen receptor, immunotherapy
• Locations: 2 sites (Duarte, California and 1 other locations)
• Trial ID: NCT06252402 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of chimeric antigen receptor (CAR) engineered T cells that are specifically designed to target HIV-1 in individuals living with the virus. The approach involves creating these CAR T cells from autologous cytomegalovirus (CMV)-specific T cells, which are expected to persist longer in the body due to ongoing stimulation by CMV antigens. Participants will be individuals with HIV-1 who are on stable antiretroviral therapy (ART) and have undetectable viral loads. The study aims to assess the safety and persistence of these engineered T cells in the body, potentially leading to improved outcomes for HIV treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are living with HIV-1, have been on stable ART with undetectable viral loads, and have a sufficient CD4+ cell count.

Not a fit: Patients with concurrent illnesses, a history of resistance to multiple antiretroviral drugs, or those who have previously received experimental HIV treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to a more effective treatment for HIV/AIDS by potentially eliminating HIV-infected cells.

How similar studies have performed: While the use of CAR T cells in HIV treatment is a novel approach, similar immunotherapy strategies have shown promise in other conditions, indicating potential for success.

Eligibility 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.

Where this trial is running

Duarte, California and 1 other locations

• City of Hope Medical Center — Duarte, California, United States (RECRUITING)
• UCSD, Division of Infectious Diseases and Global Public Health — San Diego, California, United States (RECRUITING)

Study contacts

• Principal investigator: John H. Baird, MD — City of Hope Medical Center
• Study coordinator: Marvin Hanashiro

Conditions: HIV-1, HIV-1, PLWH autologus, CMV-specific T cells, anti-retroviral therapy, Immunotherapy