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Experience and problems of the second generation CD19-CAR-T cell in the treatment of refractory relapsed acute B lymphocytic leukemia
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Abstract:
To explore the safety and effective doses of CD19 chimeric antigen receptor gene-modified T cells (CD19-CAR-T) for treating the refractory relapsed acute B lymphoblastic leukemia (R/R B-ALL)，as well as side effects and its optimal treatment methods, during July 12, 2015 to November 20, 2016 the 64 patients with R/R B-ALL were treated with the CD19-CAR-T. Among them 55 cases were recurrent primary drug-resistant or refractory patients with B-ALL, 9 cases were refractory positive minimal residual disease (MRD) patients with R/R-ALL confirmed by flow cytometry (FCM). In the early period, the 2 patients dies from treatment-related complications and their efficacy could not evaluated, and the 4 patients did not achieve complete remission (CR). After adjusting inclusion criteria and retransfusion cell numbers of CD19-CAR-T, recently the 33 patients continuously achieved RC, or achieved RC but numbers of their blood cells were not normal without any dead cases. More than 80% patients, who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) after treatment with CD19-CAR-T, continued negative MRD confirmed by FCM until end of the observation, of which efficacy was the same as that of the patients received allo-HSCT at first CR time, and most of the patients who did not receive allo-HSCT had a relapse again within 1 year after CR. In course of the treatment, keys to ensure success of the treatment should be timely and safely handling of cytokines releasing syndromes and various factors of inducing recurrent.
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