CAR-T治疗白血病:中国的多中心临床研究
  • 11例B-ALL儿童患者接受自体CD19 CART细胞输入治疗(0.45 × 10^6 - 10.51 × 10^6/kg);
  • 细胞输入7-14天后,8例CR且MRD阴性;
  • 8例细胞因子释放综合征(CRS),2例CRS严重,CAR严重患者接受IL6R抗体+甲基泼尼松龙治疗后逐渐缓解,中位CR维持时间为121天;
  • 无论患者白血病细胞负荷高低,自体CD19 CAR-T均可有效治疗复发型/难治性B-ALL,且此方法缓解率高;
  • 因CAR-T制备的高标准化与可控的CRS,在多变的临床环境下似乎并不会影响治疗结果。
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CD19 targeted chimeric antigen receptor T (CAR-T) cell immunotherapy has demonstrated significant anti-leukemia activity in pediatric patients with relapsed/refractory acute lymphocytic leukemia: A multicentre study in China

一个涉及中国多个医疗中心的研究:针对复发型/难治性急性白血病,CD19靶向性的嵌合抗原受体T细胞(CAR-T) 免疫疗法具有显著疗效

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Background: Patients with relapsed/refractory B-ALL are difficult to be treated. Autologous CD19 CAR-T may overcome many limitations of conventional therapies and induce remission in patients with relapsed/refractory disease. We explored treatment of 11 pediatric cases (come from Multicenter) with r/r B-ALL and assessed the clinical safety and efficacy.
Methods: We infused autologous CD19 CAR-T in patients at doses of 0.45 × 106 to 10.51 × 106cells per kilogram of body weight. Between Oct. 23 2015 and Jan. 12 2017, a total of 11 children from 3 clinical centers (in China) cases were treated with CAR-T cells (Table1). Patients were monitored for a response, toxic effects, and remission rate. Statistical analysis involving categorical or continuous covariates, univariates, or multivariates analyses.
Results: 73% (8/11) of the patients achieved complete remission (CR) and MRD negative between Day7-14 after CD19 CART cell infusion. 4 patients received a repeat infusions following initial ones since they have endured the Cytokine release syndrome (CRS) and have no safety concerns. Cytokine release syndrome (CRS) was seen in 73% (8/11) of patients and severe CRS occurred in 18% (2/11) of patients. Severe CRS was relieved gradually when the anti-IL6R agent tocilizumab and Methylprednisolone were administrated. 1 patients performed bone marrow transplant after they achieved MRD negative. The median CR maintenance is 121 day.
Conclusions: This effort provides the first large set of pediatrics data that describes the potential for CART19 therapy to benefit Chinese population. Autologous CD19 CAR-T was effective in treating relapsed/refractory B-ALL not only low leukemia burden, but also high-burden leukemia patients. The method also can associated with a high remission rate. Importantly, While the multicenter trial involves 3 clinical centers in China, the variable clinical settings do not seem to impact patient outcomes due to the highly standardized CAR T cell preparation protocol and manageable CRS in most.

All Authors:
Lei Xiao

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