Participants
pneumonitis, tumor, cardiovascular disease, Active hepatitis B, bowel obstruction, aggressive B cell non-Hodgkin lymphoma, renal disease, idiopathic pneumonitis, infection, B cell non-Hodgkin lymphoma, autoimmune disease
PLEURAL EFFUSION, TUMOR, PNEUMONITIS, CARDIOVASCULAR DISEASE, ORGANIZING PNEUMONIA, FOLLICULAR LYMPHOMA, DISEASE, BOWEL OBSTRUCTION, CENTRAL NERVOUS SYSTEM DISEASE, RENAL DISEASE, DRUG-INDUCED PNEUMONITIS, INFECTION, IDIOPATHIC PULMONARY FIBROSIS, AUTOIMMUNE DISEASE
Eligible patients were aged 18 years or older with histologically confirmed aggressive B cell non-Hodgkin lymphoma, diagnosed according to the 2016 World Health Organization classification criteriaThere were in total, three important protocol deviations from the inclusion criteria in the present study, which were all related to relapsed disease longer than 12 months after first-line chemoimmunotherapy. For two patients, the central histological diagnosis was not aggressive B cell non-Hodgkin lymphoma but grade 1–3A follicular lymphoma.Patients were deemed eligible for CAR-T cell therapy based on a physician’s assessment and all of the following:ECOG performance status of 0, 1 or 2.Adequate vascular access for leukapheresis (peripheral or central venous line).Absolute neutrophil count ≥1.0 × 10Platelet count ≥75 × 10Absolute lymphocyte count ≥0.1 × 10Creatinine clearance (according to the Cockcroft–Gault equation or the modification of diet in renal disease equation) ≥40 ml minSerum ALT/AST ≤ 2.5 × upper limit of normal.Total bilirubin ≤26 μmol lLeft ventricular ejection fraction ≥45%.Oxygen saturation ≥92% on room air.Key exclusion criteria included:Receipt of more than one prior line of systemic therapy.Previous CD19-targeted therapy.Cardiac involvement.Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression.Clinically significant pleural effusion.Known central nervous system disease.History of cardiovascular disease within the past 6 months.History of autoimmune disease requiring systemic immunosuppression and/or disease-modifying agents within the last year.History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis or evidence of active pneumonitis on a chest computed tomography scan at screening.Active hepatitis B or C infection or positive HIV serology at the time of screening.