GZL Sequential CD19/CD22 CAR-T in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Inclusion Criteria

• •1. Histologically confirmed CD22 + and/or CD19 + aggressive B-cell non-Hodgkin lymphoma (NHL), including the following types as defined by World Health Organization (WHO) 2016:
• •Diffuse large B-cell lymphoma (DLBCL); High grade B-cell lymphoma (HGBL); Primary mediastinal large B-cell lymphoma(PMBCL); T cell/histiocyte-rich large B-cell lymphoma (THRBCL); High grade follicular cell lymphoma Grade 3b (3bFL); Mantle cell lymphoma (MCL) except indolent; Other aggressive B-cell lymphomas.
• •2. Disease refractory to first-line therapy or early relapse within 12 months of last treatment.
• •3. Relapse or progressive disease (PD) ≥ 3 months after targeted CD19 therapy including CD19 CAR T cells or anti-CD19/anti-CD3.
• •4. Successful leukapheresis assessment and T-cell preculture.
• •5. Life expectancy \> 3 months.
• •6. Appropriate organ function:
• •Creatinine \< 1.6 mg/dL (140 µmol/L) or creatinine clearance ≥ 60ml/min; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \< 3 × upper limit of normal; Bilirubin \< 2.0 mg/dL unless subject has Gilbert 's syndrome (\< 3.0 mg/dL); Pulmonary reserve ≤ Grade 1 dyspnea and SPO2 \> 91%; Cardiac ejection fraction ≥ 50% in the absence of oxygen, no evidence of pericardial effusion as determined by echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings.
• •7. Adequate bone marrow reserve was defined as:
• •Absolute neutrophil count (ANC) \> 1000/mm3; Absolute lymphocyte count (ALC) ≥ 300/mm3; Platelet count ≥ 50,000/mm3. Hemoglobin \> 7.0 mg/dL.
• •8. Measurable or evaluable lesions according to "IWG response criteria for malignant lymphoma" (Cheson 2014).
• •9. Patients have the ability to understand and are willing to provide written informed consent.