GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms

Inclusion Criteria

• •1. Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);
• •2. Disease Assessment:
• •1. Criteria for Relapsed/Refractory lymphoid neoplasms: Meeting any one of the following three conditions: ① Failure to achieve at least a partial response (PR) per Lugano criteria after two cycles of standard first-line therapy; ② Disease progression within six months after achieving a response to first-line therapy, or progression after six months with no response to the original first-line or second-line regimen; ③ Relapse after hematopoietic stem cell transplantation.
• •2. Criteria for EBV Infection: Meeting any one of the following three conditions: ① Peripheral blood (plasma or whole blood) EBV DNA load ≥ 10³ copies/ml by quantitative PCR; ②Tumor cell GP350 positivity (≥10% of tumor cells by immunohistochemistry or flow cytometry); ③ Serological detection of EBV antibodies indicating any of the following: positive anti-VCA-IgM; positive anti-EA-IgG; or simultaneous positivity for anti-VCA-IgM, anti-VCA-IgG, and anti-EBNA-IgG.
• •3. At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection.
• •3. Performance Status: ECOG score 0-2 and expected survival ≥3 months;
• •4. Age: 18-70 years, regardless of sex;
• •5. Hematologic Criteria:
• •* Absolute neutrophil count (ANC) ≥1.0×10⁹/L;
• •* Hemoglobin \>60 g/L;
• •* CD3+ T-cell count \>0.5×10⁹/L;
• •* Platelet count \>30×10⁹/L;
• •6. Organ Function:
• •* Creatinine clearance ≥60 mL/min;
• •* ALT/AST ≤2× upper limit of normal (ULN);
• •* Total bilirubin ≤2× ULN;
• •* Left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion, and no clinically significant ECG abnormalities;
• •* Minimal or no pleural/ascitic fluid;
• •* Oxygen saturation ≥95%;
• •7. Contraception:
• •* Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception until the last follow-up;
• •* Male participants with fertile partners must agree to use effective contraception until the last follow-up;
• •8. Informed Consent: Psychologically stable, capable of understanding the study's purpose and procedures, willing to participate voluntarily, and able to provide signed informed consent and comply with protocol requirements.