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• W2892023224 abstract "3048 Background: CD19 CAR-T cell has proven efficacy for treatment of aggressive ALL. However, limited CAR-T cell persistence and/orCD19 loss are barriers to therapeutic success. Methods: A Phase I trial (NCT02028455) of CAR-T cell products consisting of purified CD4 and CD8 T cell subsets expressing uniform levels of a 4-1BB second generation CD19-specific CAR were infused following either cyclophosphamide (Cy) or fludarabine (flu/cy). Leukemic response, B-cell aplasia (BCA) and T cell persistence were evaluated by flow cytometry. Results: Products were successfully manufactured in 39/40 consecutively enrolled patients (pts) (1-25y) despite having no screening assay of lymphocyte proliferation. The ALC at time of apheresis ranged from 140-4488/µl. Of evaluable pts, 91% (33/36) achieved MRD negative (neg) CR’s in a cohort of children and young adults. The DFS and OS at 12 months are 53% and 74%. Improved disease-free survival (DFS) was observed in pts with ongoing BCA beyond day 63 (HR: 0.25 [95% CI: 0.08, 0.81], P = 0.01). For patients treated with Cy, durable engraftment of CAR T cells was positively influenced by CD19 antigen (Ag) burden (ALL + nonmalignant B cells) of > 15 % in the marrow at the time of CAR infusion (median of 4.2 v 1.4 months). This effect in 8 pts given Flu/Cy is currently under evaluation as the duration of BCA appears to also be influenced by lymphodepletion (median of 3.9 v 2.1 mo flu/cy v cy). Six patients had CD19-relapse. Conclusions: Our trial of CD19 CAR-T cell adoptive therapy has revealed a high rate of manufacturing success and MRD neg remissions. Despite high rates of MRD-neg remission, relapse is a significant etiology of treatment failure. The durability of remissions was influenced by the duration of CAR-T cell functional persistence of at least 63 days duration. Ag-driven proliferation affects the duration of B cell aplasia for pts given a Cy alone regimen. Lymphodepleting regimens also appear to influence the duration of B cell aplasia and potentially negate the effect of CD19 Ag burden. Accordingly, our program is continuing to investigate Flu/Cy conditioning regimens to improve CAR-T cell persistence. Clinical trial information: NCT02028455." @default.
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• W2892023224 date "2016-05-20" @default.
• W2892023224 modified "2023-10-05" @default.
• W2892023224 title "Prolonged functional persistence of CD19CAR t cell products of defined CD4:CD8 composition and transgene expression determines durability of MRD-negative ALL remission." @default.
• W2892023224 doi "https://doi.org/10.1200/jco.2016.34.15_suppl.3048" @default.
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