eligibility_summary
Eligible neonates: ≤21 days old, ≥34 wks GA, birth weight ≥2500 g, with CMV viremia/viruria/infection (PCR in urine/saliva/CSF/plasma or positive urine culture) and moderate/severe CMV disease, meet labs (ANC≥750, Hb≥8, Plt≥20k, Cr≤1.0, ALT/AST≤3×ULN), maternal donor with CMV-specific T-cell response (IFN-γ+ >0.01%). Exclude: steroids >0.5 mg/kg on infusion day, other CMV trials, unsafe comorbidity, maternal HIV, inability to consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase II randomized trial in neonates with moderate/severe congenital CMV tests: 1) Antiviral drugs: valganciclovir (oral prodrug) and ganciclovir (IV) — guanine nucleoside analog antivirals activated by CMV UL97 kinase that inhibit viral DNA polymerase (UL54), blocking CMV DNA synthesis/replication. 2) Biological therapy: maternal CMV-specific cytotoxic T lymphocytes (adoptive cellular immunotherapy) generated/selected with CMV PepTivators, they recognize CMV peptide–HLA complexes on infected cells and mediate antigen-specific killing via perforin/granzyme and IFN-γ, restoring antiviral adaptive immunity. Targets: CMV-infected cells, CMV antigen presentation/HLA–TCR cytotoxic pathways, and the viral DNA replication machinery.