eligibility_summary
Adults (≥18) with KPS ≥70, documented HIV‑1, on stable ART with undetectable RNA (<20 c/mL) for ≥48 weeks (≤2 blips 25–200), CD4 ≥450, adequate organ function, willing to stop ART 4 days before leukapheresis, and not pregnant/breastfeeding. Exclude those with significant comorbidity, resistance to ≥2 ART classes, or prior experimental HIV‑1 immunotherapy/gene therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: Autologous CMV/HIV-CAR T cells (biological, gene-modified T‑cell therapy). Patient CMV-specific T cells are collected and lentivirally engineered to express a CAR targeting HIV‑1 envelope gp120, product includes an EGFR tag for selection/safety. Mechanism: CAR engagement of gp120 triggers T‑cell activation and cytotoxic killing of HIV‑infected cells. Native CMV‑specific TCR signaling provides endogenous antigen-driven stimulation to enhance expansion and persistence of the infused cells in CMV‑seropositive PLWH. Targets: HIV‑infected CD4+ T cells and reservoir cells expressing gp120, CMV antigen–presenting cells that engage the CMV‑specific TCR. Key pathways: T‑cell activation, perforin/granzyme cytolysis, cytokine signaling. Dose: 5–50 million EGFR+ cells IV.