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NCT06252402 · ClinicalTrials.gov registry record · Early Phase 1
CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS
A Early Phase 1 study of HIV-1, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT06252402: Recruiting Early Phase 1 study of HIV-1, sponsored by City of Hope Medical Center.
NCT06252402 is a Early Phase 1 study of HIV-1 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 15 participants, below the 135-participant average among 9 other HIV-1 trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06252402, a Early Phase 1 study of HIV-1, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Toxicity will be graded per CTCAE v5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Criteria on CRS/Neurotoxicity: DLT.
Conditions Studied
Interventions
- BIOLOGICAL CMV/HIV-CAR T Cells
Study Locations (2)
California
- City of Hope Medical Center - Duarte
- UCSD, Division of Infectious Diseases and Global Public Health - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-12-19 |
| Est. Completion | 2026-12-11 |
| Phase | Early Phase 1 |
What NCT06252402 shows while recruiting
NCT06252402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 135-participant average among 9 other HIV-1 trials with a reported enrollment target (89% lower).
The record links to 1 condition, with HIV-1 appearing as the primary indexed condition, and to 1 intervention - of which CMV/HIV-CAR T Cells is the first listed.
NCT06252402 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06252402 about?
NCT06252402 is a clinical study titled "CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS". 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. Neverth...
What is the current status of trial NCT06252402?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2024-12-19. Estimated completion is 2026-12-11.
What conditions does trial NCT06252402 study?
This clinical trial studies the following conditions: HIV-1.
What interventions are being tested in trial NCT06252402?
The interventions under investigation include: CMV/HIV-CAR T Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06252402?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06252402 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06252402's enrollment target sits among peer trials
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