At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years
- ✓HIV-1 infection
- ✓On continuous ART ≥12 months without interruptions >14 consecutive days
- ✓Stable ART regimen without NNRTI for ≥4 weeks
- ✕Pregnant, breastfeeding, or unwilling to practice birth control
- ✕ART includes long-acting anti-HIV drug and/or NNRTI with activity up to one year post-interruption
- ✕ART includes protease inhibitors and/or AZT due to cyclophosphamide toxicity risk
- ✕History of HIV-associated malignancy including Kaposi's sarcoma or any lymphoma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Anti-HIV Activity of Autologous CD4+ and CD8+ T Cells Transduced With a Lentiviral Vector Encoding Bi-specific Anti-gp120 CAR Molecules (LVgp120duoCAR-T) in Anti-retroviral Drug-treated HIV-1 Infection
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, LVgp120duoCAR-T cells, low dose, and 2 other interventions for HIV Infections. Currently recruiting, targeting 18 participants across 2 sites.
Detailed Summary
This is a limited-center, open-label dose escalating phase I/IIa study of autologous T cells expressing LVgp120duoCAR molecules in people with HIV infection. It will follow a 3+3 design. Dose escalation decisions will be made when a minimum of three participants have completed the safety-evaluation period (45 days) at a given dose level. Cohort 1 will undergo infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 2 will undergo non-ablative conditioning with cyclophosphamide, followed by infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 3 will undergo non-ablative conditioning with cyclophosphamide, followed infusion of a single high-dose regimen of LVgp120duoCAR-T cells. Following administration of the experimental therapy, HIV medications will be paused for participants in each group during an analytic treatment interruption.
Study Details
Timeline
Interventions
Non-ablative conditioning with cyclophosphamide.
A single dose of 3 x 10\^5 cells/kg LVgp120duoCAR-T cells will be infused.
A single dose of 1 x 10\^6 cells/kg LVgp120duoCAR-T cells will be infused.
HIV antiretroviral therapy medications will be paused.