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This is an investigational autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy developed and manufactured in-house at Sheba Medical Center. While CD19 is traditionally a B-cell marker, it is aberrantly expressed in approximately 50-80% of acute myeloid leukemia (AML) patients with the t(8;21) translocation. The therapy involves genetically modifying a patient's own T-cells to express a CAR that targets and eliminates CD19-positive leukemic blasts. Produced as a point-of-care biologic, it features a rapid manufacturing turnaround of approximately 10 days. Clinical evaluation is currently focused on patients with relapsed or refractory AML who exhibit both the t(8;21) genetic abnormality and CD19 expression.
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