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UCART19 is a first-in-class, allogeneic (off-the-shelf) genome-edited chimeric antigen receptor T-cell (CAR-T) therapy targeting CD19. It is manufactured from healthy unrelated donor T cells that are genetically modified to express an anti-CD19 CAR and to disrupt genes encoding the T-cell receptor α and β chains as well as CD52. This engineering reduces the risk of graft-versus-host disease and confers resistance to anti-CD52 monoclonal antibody lymphodepletion regimens such as alemtuzumab[2][5]. The primary indication for UCART19 has been relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), both in pediatric and adult patients[1][3][6]. Clinical studies have demonstrated manageable safety, with cytokine release syndrome, infections, cytopenias, and mild graft-versus-host disease among observed toxicities[1][3]. The product was developed by Servier in collaboration with Allogene Therapeutics/Cellectis[4][5].
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