eligibility_summary
Include: CAEBV (WHO 2016, non‑B) or EBV‑LPD age 2–70, or PTLD after SOT/HSCT age 18–70, EBV‑DNA ≥1000/mL or EBER+, adequate organ function and blood counts (incl LVEF ≥50%), negative pregnancy test/contraception, consent/compliance. Exclude: other trials, pregnancy/lactation, severe organ disease/failure, aGVHD III–IV or cGVHD (PTLD), DIC, uncontrolled HTN/DM, GI bleed, active infections (TB/bacterial/fungal ≥G2, recent herpes), autoimmune disease, psych/substance abuse, other diagnoses, investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06666153 (Phase 1, single‐arm dose escalation) in CAEBV/EBV‑LPD and PTLD. Interventions: 1) EBV immunological agent (biological, intradermal/subcutaneous, dose-escalation: children 5×10^5–5×10^6, adults 5×10^6–5×10^7). Mechanism: therapeutic EBV-directed immunotherapy designed to elicit/boost EBV-specific cellular immunity (cytotoxic T‑cell responses) against EBV antigens on infected lymphocytes. 2) Toripalimab 240 mg, a monoclonal antibody PD‑1 inhibitor (checkpoint blockade) to reinvigorate exhausted T cells and enhance anti‑EBV activity. Targets: EBV-infected lymphocytes—B cells (notably in PTLD) and T/NK cells (in CAEBV/LPD), immune pathways include PD‑1/PD‑L1 axis and EBV‑specific CTL activation via antigen presentation in skin/SC tissues. Primary focus: safety/tolerability and initial efficacy.