eligibility_summary
Eligibility: 18–75, able to consent, post‑allogeneic HSCT, with significant CMV that is refractory (≥1‑log rise after 2 wks), probable refractory (persistent/≤1‑log rise), resistant (mutation), refractory CMV disease, or unable to take standard drugs due to cytopenias (ANC<1000, Plt<100k) or nephrotoxicity (Cr≥1.5× baseline). Negative pregnancy test/contraception. Exclude: allergy to murine Ab/iron‑dextran, grade 3–4/active GVHD, pregnant/lactating, uncontrolled bacterial/fungal infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: ImmuneCellVir-I, an allogeneic, off-the-shelf adoptive T-cell therapy (combination product) consisting of donor CMV-specific T lymphocytes expanded ex vivo, stimulated with CMV pp65 peptide, and selected by interferon-gamma capture. Mechanism of action: HLA-restricted, antigen-specific TCR recognition of CMV-infected cells, CD4+ T cells provide cytokine help, and CD8+ T cells kill infected cells via perforin/granzyme, augmenting antiviral immunity and immune reconstitution in post-transplant patients refractory or intolerant to antivirals. Targets: CMV-infected host cells expressing CMV pp65, pathways include TCR–MHC recognition, IFN-gamma signaling, and cytotoxic effector pathways. Monitoring focuses on CMV viral load reduction and anti-CMV T-cell responses (ELISpot).