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• W4205506089 abstract "Abstract Background: Anti-CD19 chimeric antigen receptor (CAR) T cell therapy has been an effective salvage therapy for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Hematological toxicity is one of the adverse events (AEs) of this therapy. But the underlying pathophysiologic mechanism of persistent cytopenia is unclear. The association of persistent cytopenia with the efficacy and side effects of anti-CD19-CAR T cell therapy should be concerned about. Patients and methods: In this work, 38 R/R DLBCL patients were enrolled in clinical trial of anti-CD19-CAR T-cell therapy. Before CAR T-cell therapy, all the patients received lymphodepleting chemotherapy with fludarabine and cyclophosphamide. The degree and duration of cytopenia, clinical response, proportions of CAR T-cells and levels of interleukin-6 (IL-6), AEs and follow up were observed following the anti-CD19-CAR T-cell therapy. Results: The 3-4 grade of persistent cytopenia occurred in 14 R/R DLBCL patients (more than 8 weeks after CAR-T cell infusion) and recovered at 8-18 weeks after CAR-T cell infusion. All these 14 patients achieved objective response rate (ORR) in their anti-CD19-CAR T cell therapy. In the 26 patients obtained ORR, the incidence of 3-4 grade of persistent cytopenia was higher in patients with high tumor load than that of patients without high tumor load. The mean peak of IL-6 and anti-CD19-CAR T cells, the grade of CRS in patients with 3-4 grade of persistent cytopenia were higher than that of patients without such persistent cytopenia. Most patients whose anti-CD19-CAR T cells could be observed at 21 and 28 days after infusion were associated with 3-4 grade of persistent cytopenia. The PFS and OS were higher in patients with 3-4 grade of persistent cytopenia. Conclusion: All the R/R DLBCL patients who occurred 3-4 grade of persistent cytopenia after anti-CD19-CAR T cell therapy achieved ORR in this therapy. The 3-4 grade of persistent cytopenia was associated with high tumor load, higher peaks of IL-6 and anti-CD19-CAR T cells, higher grades of CRS, the higher PFS and OS. Our study is helpful in predicting efficacy and severe hematologic side effects of anti-CD19-CAR T-cell therapy in R/R DLBCL patients. Trial registration: The study was registered at http://www.chictr.org.cn/index.aspx as ChiCTR-ONN-16009862 and http://www.chictr.org.cn/index.aspx as ChiCTR1800019622 ." @default.
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• W4205506089 date "2022-01-18" @default.
• W4205506089 modified "2023-09-27" @default.
• W4205506089 title "Association Analysis of Persistent Cytopenia With Efficacy and Side Effects of Anti-CD19 CAR T Therapy in Relapsed/refractory Diffuse Large B-Cell Lymphoma Patients." @default.
• W4205506089 doi "https://doi.org/10.21203/rs.3.rs-1254282/v1" @default.
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