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CARLA-M19 is an autologous chimeric antigen receptor (CAR) T-cell therapy targeting the CD19 antigen, developed by the University Hospital, Lille. While CD19 is primarily a B-cell marker, it is aberrantly expressed in specific subsets of acute myeloid leukemia (AML), such as those harboring the t(8;21) translocation. The treatment involves the genetic modification of a patient's own T cells to express a CAR specific for CD19, which are then expanded using the CliniMACS Prodigy semi-automated bioreactor system. Following lymphodepleting conditioning with cyclophosphamide and fludarabine, the engineered cells are re-infused into the patient to induce targeted tumor cell lysis. It is currently being evaluated in a Phase I clinical trial for patients with relapsed or refractory CD19-positive AML.
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