贝林妥欧单抗与CD19 CAR-T细胞治疗急性B淋巴细胞白血病的安全性和短期疗效比较分析*

doi:10.3969/j.issn.1671-2587.2025.02.013

临床输血与检验 ›› 2025, Vol. 27 ›› Issue (2): 224-233.DOI: 10.3969/j.issn.1671-2587.2025.02.013

贝林妥欧单抗与CD19 CAR-T细胞治疗急性B淋巴细胞白血病的安全性和短期疗效比较分析^*

徐慧, 张全诚, 许倩文, 薛磊, 王兴兵

中国科学技术大学附属第一医院（安徽省立医院）血液科,安徽合肥 230001

收稿日期:2024-11-02 出版日期:2025-04-20 发布日期:2025-04-17
通讯作者: 王兴兵,主要从事血液系统疾病的免疫治疗方向研究,（E-mail）wangxingbing@ustc.edu.cn。
作者简介:徐慧,主要从事血液系统疾病如白血病、淋巴瘤等方面研究,（E-mail）275864329@qq.com。
基金资助:
*本课题受国家自然科学基金项目（No.82170221）、安徽医科大学领先医学与先进技术研究中心项目（No.2023IHM01010）、安徽省重点研发计划项目（No.2022e07020022）资助

Comparative Analysis of Safety and Short-term Efficacy of Blinatumomab Versus Anti-CD19 CAR-T Cell Therapy in the Treatment of Acute B Lymphoblastic Leukemia

XU Hui, ZHANG Quancheng, XU Qianwen, XUE Lei, WANG Xingbing

Department of Hematology, First Affiliated Hospital of USTC (Anhui Provincial Hospital), HeFei 230001

Received:2024-11-02 Online:2025-04-20 Published:2025-04-17

摘要/Abstract

摘要： 目的本文回顾性分析了我院接受贝林妥欧单抗和CD19 CAR-T细胞治疗急性B淋巴细胞白血病（B-ALL）患者的安全性、有效性及短期预后,并识别在不同基线特征的患者群体中两组之间的疗效差异。方法本研究共纳入2021—2023年接受贝林妥欧单抗治疗的21例患者和2016—2020年接受CD19 CAR-T细胞治疗的80例患者,先评估两组患者临床疗效,再通过亚组分析,在不同基线特征的患者中进行安全性、疗效和短期随访的比较,最后比较两种治疗后桥接移植对患者预后的影响。结果在贝林妥欧单抗组中,52.4%（11/21）的患者出现了细胞因子释放综合征（CRS）,但无重度CRS及神经毒性发生,90.5%达到了微小残留病（MRD）阴性疾病缓解（CR）。相比之下,CAR-T组中有95.5%（64/67）的患者出现CRS,其中38.9%（26/67）为严重病例,86.7%实现了MRD阴性CR。根据亚组分析结果显示,不论治疗前肿瘤负荷或复发次数,贝林妥欧单抗组CRS反应较轻（P<0.05）,并且两组疗效相当。贝林妥欧单抗组的中位无进展生存期（PFS）和总生存期（OS）尚未达到,12个月的PFS和OS率分别为70.7%和88.1%。CAR-T组的中位PFS和OS分别为12.3个月和19.0个月,12个月的PFS和OS率分别为52.0%和62.4%。接受治疗后脐带血移植（UCBT）的患者PFS显著改善（贝林妥欧单抗组P=0.010,CAR-T组P<0.001）。结论在不同肿瘤负荷和复发次数的B-ALL患者中,贝林妥欧单抗疗效与CD19 CAR-T细胞治疗相当,而CRS反应较低。治疗后进行脐带血移植显著提高了患者的生存率。但由于贝林妥欧单抗组的样本量和随访时间有限,需进一步扩大临床研究以确认长期疗效。

关键词: CD19 CAR-T细胞治疗, 贝林妥欧单抗, 急性B淋巴细胞白血病, 造血干细胞移植

Abstract: Objective This retrospective study is to compare the safety, efficacy and short-term outcomes between blinatumomab and anti-CD19 CAR-T cell therapy in B-ALL patients treated at our institution. Methods The cohort included 21 patients treated with blinatumomab (2021—2023) and 80 patients treated with anti-CD19 CAR-T cells (2016—2020). Results In blinatumomab group, 52.4% (11/21) of patients experienced cytokine release syndrome (CRS), with no severe CRS or neurotoxicity reported, and 90.5% achieved MRD-negative complete remission (CR). In contrast, 95.5% (64/67) of patients in the CAR-T group experienced CRS, with 38.9% (26/67) classified as severe cases, and 86.7% achieved MRD-negative CR. Based on the results of the subgroup analysis, blinatumomab was associated with milder CRS compared to CAR-T therapy, regardless of pre-treatment tumor burden or relapse status (P<0.05). The efficacy between the two groups was comparable. The median progression-free survival (PFS) and overall survival (OS) were not reached in the blinatumomab group, with 12-month PFS and OS rates of 70.7% and 88.1%, respectively. In the CAR-T group, the median PFS and OS were 12.3 months and 19.0 months, with 12-month rates of 52.0% and 62.4%. Patients who underwent umbilical cord blood transplantation (UCBT) post-treatment had significantly improved PFS (P=0.010 for blinatumomab, P<0.001 for CAR-T). Conclusion In patients with B-ALL across varying tumor burdens and relapse counts, the efficacy of blinatumomab was comparable to that of CD19 CAR-T cell therapy, with a notably lower incidence of cytokine release syndrome (CRS). Post-treatment UCBT significantly enhanced patient survival. However, due to limited sample size and follow-up duration for the blinatumomab group, further research is needed to confirm the long-term efficacy.

Key words: Anti-CD19 CAR-T cell therapy, Blinatumomab, Acute B lymphoblastic leukemia, Hematopoietic stem cell transplantation

中图分类号:

R733.71R979.1

徐慧, 张全诚, 许倩文, 薛磊, 王兴兵. 贝林妥欧单抗与CD19 CAR-T细胞治疗急性B淋巴细胞白血病的安全性和短期疗效比较分析^*[J]. 临床输血与检验, 2025, 27(2): 224-233.

XU Hui, ZHANG Quancheng, XU Qianwen, XUE Lei, WANG Xingbing. Comparative Analysis of Safety and Short-term Efficacy of Blinatumomab Versus Anti-CD19 CAR-T Cell Therapy in the Treatment of Acute B Lymphoblastic Leukemia[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2025, 27(2): 224-233.

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贝林妥欧单抗与CD19 CAR-T细胞治疗急性B淋巴细胞白血病的安全性和短期疗效比较分析^*

Comparative Analysis of Safety and Short-term Efficacy of Blinatumomab Versus Anti-CD19 CAR-T Cell Therapy in the Treatment of Acute B Lymphoblastic Leukemia

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