Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
Trial Parameters
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Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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\~4) × 10\^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation. Exclusion Criteria: * Patients with uncontrolled active aGVHD one day before TCR-T cell infusion. * Patients with severe kidney disease (Cr \> 3×normal value), liver damage (TBIL \>2.5×upper limit of normal value, ALT and AST \> 3×upper limit of normal value) or heart failure (NYHA heart function grade IV or left ventri