eligibility_summary
Eligible: CMV+ and EBV+, HLA‑A0201+, ≥18, ECOG 0–1, adequate organ function, NYHA I, O2 ≥90%, recovered to ≤G1 tox, washouts: chemo ≥28d, targeted/immuno ≥45d (anti‑VEGF ≥2mo), palliative RT ≥7d, contraception, consent. Exclude: pregnancy/breastfeeding, anticoagulation pause unsafe, NYHA ≥II/serious arrhythmia, CNS mets, active autoimmune (tx ≤2y), live vaccine <30d, immunodeficiency or steroids >10 mg, prior transplant, severe PD‑1/PD‑L1 rxn, pneumonitis, active infection, HIV/HBV/HCV viremia, TB, investigational <4w, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT05338658 (Phase I, suspended). Intervention: Peptide Alarm Therapy (PAT) given by intratumoral injection on Days 1 and 3 during the first cycle, combined with a PD‑1/PD‑L1 inhibitor (dose finding with pembrolizumab 200 mg q3w, expansion with disease‑appropriate PD‑1/PD‑L1 blockade). Drug types/mechanisms: • PAT is a peptide-based immunotherapy intended to locally present immunogenic viral peptides (patients must be CMV/EBV seropositive and HLA‑A0201+) to “alarm” and recruit pre‑existing virus‑specific memory CD8+ T cells, triggering cytotoxicity, inflammatory cytokines, dendritic cell activation, and epitope spreading to tumor antigens. • PD‑1/PD‑L1 inhibitors are monoclonal antibodies that block the PD‑1 checkpoint to reverse T‑cell exhaustion and enhance antitumor activity. Targets: virus‑specific memory CD8+ T cells (CMV/EBV), tumor-infiltrating lymphocytes, dendritic cells, pathways include MHC‑I antigen presentation and the PD‑1/PD‑L1 axis.