Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) or EBV infection
• Age 1-60 years, gender unlimited.
• Diagnosed with EBV associated-hemophagocytic lymphohistiocytosis (HLH) or EBV infection.
• Fully understood and informed the study and signed the ICF.
• Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age\<16y).
• TCRT-T cell donor inclusion criteria: 1)Age \>=8 years, gender unlimited; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8\
⁃ × 10\^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.