Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)

Critères d'inclusion

• Age ≥ 18 years • Diagnosis of B-cell NHL or B-ALL with relapsed, refractory disease and no available standard therapeutic options (including commercially accessible CAR T products), including: • Acute B-lymphoblastic leukaemia • Burkitt lymphoma • Primary CNS lymphoma • DLBCL or high-grade lymphoma of any subtype • Primary mediastinal B cell lymphoma (including grey zone lymphoma) • Mantle Cell lymphoma • Low-grade B-cell NHLs: Follicular lymphoma, chronic lymphocytic leukaemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma, hairy cell leukaemia, splenic B-cell lymphoma/leukaemia with prominent nucleoli, and lymphoplasmacytic lymphoma • CD19 and/or CD20 positive disease on most recent evaluation (by immunohistochemistry or flow cytometry) • ECOG clinical performance status ≤2 • Able to provide written informed consent. • Adequate organ function and bone marrow reserve, unless clearly caused by lymphoma and considered reversible, defined as: • Adequate hepatic function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3.0 × (ULN) and serum bilirubin ≤2.0 × ULN (except in congenital hyperbilirubinemia, such as Gilbert syndrome, where direct bilirubin ≤3.0 × ULN is allowed) • Adequate renal function: creatinine clearance ≥30 mL/min/1.73 m2 • Adequate pulmonary function: Forced Expiratory Volume in 1 second (FEV1) ≥50% (with adequate compliance) and pulse oxygenation \> 91% with room air. • Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 40%, and no clinically significant arrhythmia • Adequate bone marrow reserve (Hemoglobin ≥80 g/L (with or without recombinant erythropoietin or red blood cell transfusions), Platelets ≥ 50×10\^9/L (with or without platelet transfusions), Absolute Neutrophil Count (ANC) 1.0 ×10\^9/L (prior growth factor support is permitted but must be without support in the 7 days before the laboratory test), Absolute Lymphocyte Count ≥0.3 ×10\^9/L) • Willingness to practice highly effective methods of birth control, and, in females of childbearing potential, negative urine or serum pregnancy test before study inclusion, lymphapheresis, and lymphodepleting chemotherapy.