eligibility_summary
Eligible patients: age 1–60, EBV‑HLH or EBV infection, consented, KPS≥70 (≥16y) or Lansky≥50 (<16y). Donors: ≥8y, consented, ≥3/6 HLA match, lymphocytes 0.8–4×10^9/L, adequate veins. Exclude: uncontrolled aGVHD, severe renal/hepatic/cardiac failure, planned immunosuppression, recent (≤2 wks) immunosuppressants/G‑CSF, active malignancy, HIV/TAP+, pregnancy/lactation, no contraception, other cell therapy ≤4 wks, other trial ≤4 wks, albumin allergy. Donor exclude: pregnancy, HBsAg/HCV/HIV/TAP+, EBV‑DNA/CMV‑DNA+, infection, recent immunosuppressants/G‑CSF.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial NCT06135922 tests EBV-TCR-T cells, an allogeneic engineered T‑cell therapy (biologic). Donor T cells are transduced ex vivo with a lentiviral vector to express an Epstein–Barr virus (EBV)–specific T-cell receptor restricted to HLA-A02:01/11:01/24:02, then infused at 1×10^6–1×10^8 cells/kg. Mechanism: adoptive cellular immunotherapy, the introduced TCR recognizes EBV-derived peptides presented on HLA class I, activating cytotoxic T-cell pathways (TCR signaling, perforin/granzyme) to eliminate EBV-infected cells and reduce viral load/inflammation driving EBV-associated hemophagocytic lymphohistiocytosis (HLH) or persistent EBV infection. Target cells/pathways: EBV-infected host cells (commonly B cells, and in EBV-HLH often T/NK cells) presenting EBV antigens via MHC I, downstream immune effector pathways and cytokine milieu are monitored. Phase I, multicenter, open-label, single-arm in China, endpoints include safety, efficacy, pharmacokinetics, and cytokines.