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异基因 CD56+细胞输注作为复发/难治性急性髓系白血病造血干细胞移植的桥接治疗:一项 I 期临床试验

英文原题:Allogeneic CD56 + cell infusion as a bridge to hematopoietic stem cell transplantation in relapsed/refractory acute myeloid leukemia: a phase I clinical trial.

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Allogeneic CD56 + cell infusion as a bridge to hematopoietic stem cell transplantation in relapsed/refractory acute myeloid leukemia: a phase I clinical trial.

PubMed 2026/03/31(内容时间) Cancer Immunol Immunother Q1 · IF 5.8(JCR 2025)

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研究概要

这些试验表明 FLAG 方案化疗联合异基因 KIR 配体错配的 CD56+NK/NKT 样细胞输注是安全的,并可能作为 36.3% 的难治/复发性非 M3 AML 患者通往 HSCT 的有效桥接。

研究思路结论见上方概要

急性髓系白血病(AML)是一种侵袭性疾病,总生存率欠佳,尤其是在复发/难治性患者中。这类患者挽救治疗的主要目标是实现最佳疾病控制,从而能够过渡到造血干细胞移植(HSCT),而HSCT仍是其中一部分患者唯一的治愈选择。异基因KIR配体错配的CD56+NK/NKT样细胞已显示出抗白血病活性,并为开发新型细胞疗法提供了一个有前景的平台。

复发/难治性非M3 AML患者,不适合HSCT者被纳入这项I期临床试验。患者接受FLAG预处理方案,随后以5天间隔接受三个递增剂量(1 × 10⁶、3 × 10⁶、5 × 10⁶ cells/kg)的CD56 + NK/NKT样细胞。

共11例患者入组研究,中位年龄41.5岁。他们平均接受过三线既往化疗,骨髓中原始细胞比例为18%。CD56⁺ NK/NKT样细胞输注是安全的,未在任何患者中观察到严重毒性或移植物抗宿主病(GVHD)。遵循该治疗方案后,五例患者(45.4%)达到完全缓解(CR),伴或不伴血细胞计数恢复。其中四例患者(36.3%)成功接受HSCT,并至随访期结束时保持无事件。

展开英文摘要原文

A total of 11 patients with a median age of 41.5 years were enrolled in the study. On average, they received three lines of prior chemotherapy and showed 18% blasts in their bone marrow. The infusion of CD56⁺ NK/NKT-like cells was safe, with no serious toxicity or graft-versus-host disease (GVHD) observed in any patient. Following this treatment protocol, five patients (45.4%) achieved complete remission (CR), with or without hematologic count recovery. Four of these patients (36.3%) underwent successful HSCT and remained event-free to the end of the follow-up period.

Overall, these trials indicated that the FLAG regimen chemotherapy combined with allogeneic KIR ligand-mismatched CD56 + NK/NKT-like cell infusion is safe and may serve as an effective bridge to HSCT in 36.3% of patients with refractory/relapsed non-M3 AML.

论文信息

作者
Ghasabeh AS、Izadpanah A、Bakhtiyaridovvombaygi M、Seresht-Ahmadi M、Parkhideh S、Seraji HR、Sabri A、Yazdanparast S
第一作者单位
Laboratory Hematology and Blood Bank Department, School of Allied Medical Science, Shahid Beheshti University of Medical Science, Tehran, Iran.Iran
通讯作者单位
Hematopoietic Stem Cell Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. elham.roshandel@gmail.com.Iran
文献类型
I 期临床试验
期刊
Cancer immunology, immunotherapy : CII2026 Mar 31
原文标识
PubMed 41915180 · DOI 10.1007/s00262-025-04285-9