CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)

Inclusion Criteria19

• Signed informed consent.
• Relapsed or refractory CD20+ diffuse large B-cell lymphoma, mantle cell lymphoma or indolent lymphoma.
• The patient should have been treated with at least two lines of therapy and have no curative treatment option, specifically
• Relapsed or refractory CD20+ B-cell lymphoma that are not eligible to receive clinically approved CD19-directed CAR T cell treatment.
• Relapsed or refractory CD20+ B-cell lymphoma who are CD19 negative.
• Relapsed or refractory B-cell lymphoma who relapse after CD19 CAR T cell treatment.
• In phase I age \>18 years, in phase II all ages
• Measurable disease per Lugano classification.
• Performance status ECOG 0-2.
• Adequate bone marrow function as evidenced by:
• Absolute neutrophil count (ANC) ≥ 1x10\^9/l/L
• Platelet ≥ 50x 10\^9/l
• Absolute lymphocyte count ≥ 0,1x10\^9/L
• Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:
• Creatinine clearance (Cockcroft Gault) ≥ 30 mL/min
• Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN) and S-Bilirubin \<1.5x UNL
• Cardiac ejection fraction ≥ 40%
• Functional venous for administration of IMP.
• Fertile individuals must consent to use contraceptives during participation in the trial.