Modified manufacturing process modulates CD19CAR T-cell engraftment fitness and leukemia-free survival in pediatric and young adult subjects

F Ceppi, AL Wilson, C Annesley, GR Kimmerly… - Cancer immunology …, 2022 - AACR
F Ceppi, AL Wilson, C Annesley, GR Kimmerly, C Summers, A Brand, K Seidel, QV Wu
Cancer immunology research, 2022AACR
T cells modified to express a chimeric antigen receptor (CAR) targeting CD19 can induce
potent and sustained responses in children with relapsed/refractory acute lymphoblastic
leukemia (ALL). The durability of remission is related to the length of time the CAR T cells
persist. Efforts to understand differences in persistence have focused on the CAR construct,
in particular the costimulatory signaling module of the chimeric receptor. We previously
reported a robust intent-to-treat product manufacturing success rate and remission induction …
Abstract
T cells modified to express a chimeric antigen receptor (CAR) targeting CD19 can induce potent and sustained responses in children with relapsed/refractory acute lymphoblastic leukemia (ALL). The durability of remission is related to the length of time the CAR T cells persist. Efforts to understand differences in persistence have focused on the CAR construct, in particular the costimulatory signaling module of the chimeric receptor. We previously reported a robust intent-to-treat product manufacturing success rate and remission induction rate in children and young adults with recurrent/refractory B-ALL using the SCRI-CAR19v1 product, a second-generation CD19-specific CAR with 4-1BB costimulation coexpressed with the EGFRt cell-surface tag (NCT02028455). Following completion of the phase I study, two changes to CAR T-cell manufacturing were introduced: switching the T-cell activation reagent and omitting midculture EGFRt immunomagnetic selection. We tested the modified manufacturing process and resulting product, designated SCRI-CAR19v2, in a cohort of 21 subjects on the phase II arm of the trial. Here, we describe the unanticipated enhancement in product performance resulting in prolonged persistence and B-cell aplasia and improved leukemia-free survival with SCRI-CAR19v2 as compared with SCRI-CAR19v1.
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