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

RecruitingEARLY Phase 1Ages 18 Years - anyAllCity of Hope Medical Center
NCT06252402 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 ce

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participant must be โ‰ฅ 18 years of age at the time of screening; * Karnofsky Performance Status (KPS) โ‰ฅ 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 โ‰ฅ 450 cells/ฮผL; * 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.
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What it tests

  • CMV/HIV-CAR T Cells
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Where

2 sites
City of Hope Medical Center
Duarte, United States
UCSD, Division of Infectious Diseases and Global Public Health
San Diego, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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