RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-30
Study Completion:2026-12-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06252402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be ≥ 18 years of age at the time of screening;
  2. * Karnofsky Performance Status (KPS) ≥ 70;
  3. * Documented HIV-1 infection anytime prior to study entry.;
  4. * 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);
  5. * CD4+ cell count ≥ 450 cells/μL;
  6. * Adequate organ function;
  7. * Willingness to interrupt ART regimen for 4 days prior to leukapheresis;
  8. * Not pregnant or breastfeeding.
  1. * Concurrent illness or comorbid condition;
  2. * History of resistance to two or more classes of antiretroviral drugs;
  3. * History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.

Contacts and Locations

Study Contact

Marvin Hanashiro
CONTACT
(619) 543-3740
mhanashiro@health.ucsd.edu
Steven Hendrickx
CONTACT
(619) 543-6968
smhendrickx@health.ucsd.edu

Principal Investigator

John H. Baird, MD
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
David (Davey) Smith, MD
PRINCIPAL_INVESTIGATOR
UCSD, San Diego Center for AIDS Research

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
UCSD, Division of Infectious Diseases and Global Public Health
San Diego, California, 92093
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • John H. Baird, MD, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center
  • David (Davey) Smith, MD, PRINCIPAL_INVESTIGATOR, UCSD, San Diego Center for AIDS Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-30
Study Completion Date2026-12-11

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2026-12-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • HIV-1