Axicabtagene Ciloleucel Sample Clauses

Axicabtagene Ciloleucel. Axicabtagene ciloleucel is manufactured for subjects with lymphomas that are characterized as not being associated with circulating tumor cells (ie, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma). Briefly, peripheral blood mononuclear cells (PBMCs) are obtained by leukapheresis and Ficoll separation. PBMCs are activated by culturing with an anti-CD3 antibody in the presence of recombinant IL-2. Stimulated cells are transduced with a retroviral vector containing an anti-CD19 CAR gene and propagated in culture to generate sufficient engineered T cells for administration. Patients with r/r MCL may have tumor cells in the peripheral blood, which is associated with a poor prognosis (Xxxxxxxx et al, 1997). When the first 10 subjects in Cohort 1 were dosed with axicabtagene ciloleucel, it was observed that the incidence and amount of circulating leukemic phase MCL appeared to be higher than rates that are typically for MCL (Xxxxxxxx et al, 1997; Xxxxx et al, 2015; Xxxxx et al, 2016). Because the axicabtagene ciloleucel manufacturing process is not optimized to remove circulating tumor cells from the manufacturing process stream, all subsequent patients were dosed using KTE-X19.
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