Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19 hematologic indications.

Background Aims: Autologous chimeric antigen receptor (CAR) T-cell therapies have demonstrated substantial clinical benefit across several hematologic malignancies. However, patient-to-patient variability and heterogeneity of starting cellular material across patient populations and disease indications pose challenges to manufacturing consistency. Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, defined-composition, 4-1BB CAR T-cell product administered at equal target doses of CD8 and CD4 CAR T cells.