Comparison of Point-of-care Produced CAR T-cell With Commercial CAR T-cells in Patients With R/R LBCL (HOVON161)

Inclusion Criteria: Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B, T-cell/histocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, transformed lymphoma (transformed follicular) and R/R after at least 2 lines of systemic therapy Age ≥ 18 and ≤80 years Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0-2 (appendix D) If the patient has a history of central nervous system (CNS) involvement, then he/she must have No signs or symptoms of CNS involvement No active disease on magnetic resonance imaging (MRI) Absence of large cell lymphoma in cerebral spinal fluid (CSF) on cytospin preparation or flow cytometry, regardless of the number of white blood cells Estimated life expectancy of >3 months other than primary disease Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen Signed and dated informed consent before conduct of any trial-specific procedure Patient is capable of giving informed consent Exclusion Criteria: Absolute neutrophil count (ANC) <1.0x109/L Platelet count <50x109/L Absolute lymphocyte count <0.1x109/L Primary CNS lymphoma Known history of infection with hepatitis C or B virus unless treated and confirmed to be polymerase chain reaction (PCR) negative HIV infection Known history or presence of seizure activities or on active anti- seizure medications within the previous 12 months Known history of CVA within prior 12 months Unstable neurological deficits Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease Active systemic autoimmune disease for which immunosupressive therapy is required Presence of CNS disease that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity, baseline dementia that would interfere with therapy or monitoring, determined using mini-mental status exam at baseline Active systemic fungal, viral or bacterial infection Clinical heart failure with New York Heart Association class ≥2 (appendix F) or Left Ventricular Ejection Fraction (LVEF) <40% Resting oxygen saturation <92% on room air Liver dysfunction as indicated by total bilirubin, AST and/or ALT >5 x institutional ULN, unless directly attributable to the lymphoma or Gilbert disease GFR <40 mL/min calculated according to the modified formula of Cockcroft and Gault or by direct urine collection Pregnant or breast-feeding woman Active other malignancy requiring treatment Medical condition requiring prolonged use of systemic immunosuppressives with exception of prednisolone <10 mg/day History of severe immediate hypersensitivity reaction against any drug or its Ingredients/impurities that is scheduled to be given during trial participation e.g. as part of the mandatory lymphodepletion protocol, premedication for infusion, or rescue medication/salvage therapies for treatment related toxicities Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule