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MB-HUCART19.1 is an autologous, humanized chimeric antigen receptor (CAR) T-cell therapy targeting the CD19 antigen, a protein widely expressed on the surface of B-cells. Developed by the Prinses Máxima Centrum voor Kinderoncologie in collaboration with Miltenyi Biotec, this therapeutic candidate is specifically designed for pediatric and young adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). The HU in the name signifies the use of a humanized single-chain variable fragment (scFv) in the CAR construct, which is intended to reduce the risk of immune-mediated rejection (anti-CAR immune responses) and enhance the persistence of the CAR-T cells in the patient's bloodstream compared to traditional murine-based CARs. The manufacturing process utilizes the Miltenyi Biotec CliniMACS Prodigy platform for automated, closed-system production.
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