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Hemato-Oncologie voor Volwassenen Nederland","100488539","phase-2-comparison-of-point-of-care-produced-car-t-cell-with-commercial-car-t-cells-in-patients-with-rr-lbcl-100488539",false,"NCT05641428","Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R\u002FR LBCL","A Phase II Non-inferiority Study Comparing Point-of-care Produced CAR T-cell to Commercial CAR T-cells in Patients with Relapsed\u002Frefractory Non-Hodgkin Lymphoma","HOVON161","Inclusion Criteria:\n\n* 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\u002For BCL6 rearrangements with DLBCL histology (DHL\u002FTHL) and FL3B, T-cell\u002Fhistocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, transformed lymphoma (transformed follicular) and R\u002FR after at least 2 lines of systemic therapy\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG)\u002FWHO performance status 0-2\n* Secondary central nervous system (CNS) involvement is allowed however, then he\u002Fshe must have\n\n  \\* No signs or symptoms of CNS involvement that would hamper adequate ICANS assessment\n* Estimated life expectancy of \\>3 months other than primary disease\n* 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\n* Signed and dated informed consent before conduct of any trial-specific procedure\n* Patient is capable of giving informed consent\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\<1.0x10\\^9\u002FL\n* Platelet count \\<50x10\\^9\u002FL\n* Absolute lymphocyte count \\<0.1x10\\^9\u002FL\n* Primary CNS lymphoma\n* Known history of infection with hepatitis C or B virus unless treated and confirmed to be polymerase chain reaction (PCR) negative\n* Active HIV infection with detectable viral load or CD4 T-cell count below 0.20x10\\^9\u002FL\n* Known history or presence of seizure activities or on active anti- seizure medications within the previous 12 months\n* Known history of CVA within prior 12 months\n* Unstable neurological deficits\n* Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease\n* Active systemic autoimmune disease for which immunosupressive therapy is required\n* 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\n* Active systemic fungal, viral or bacterial infection\n* Clinical heart failure with New York Heart Association class ≥2 (appendix F) or Left Ventricular Ejection Fraction (LVEF) \\<40%\n* Resting oxygen saturation \\<92% on room air\n* Liver dysfunction as indicated by total bilirubin, AST and\u002For ALT \\>5 x institutional ULN, unless directly attributable to the lymphoma or Gilbert disease\n* GFR \\<40 mL\u002Fmin calculated according to the modified formula of Cockcroft and Gault or by direct urine collection\n* Pregnant or breast-feeding woman\n* Active other malignancy requiring treatment\n* Medical condition requiring prolonged use of systemic immunosuppressives with exception of prednisolone \\<10 mg\u002Fday\n* History of severe immediate hypersensitivity reaction against any drug or its Ingredients\u002Fimpurities that is scheduled to be given during trial participation e.g. as part of the mandatory lymphodepletion protocol, premedication for infusion, or rescue medication\u002Fsalvage therapies for treatment related toxicities\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule","ALL","18 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