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<p>CLL1-targeted chimeric antigen receptor T (CAR-T) cell therapy has shown clinically meaningful activity in relapsed/refractory acute myeloid leukemia (R/R AML). This updated phase I study enrolled 38 adults with R/R AML to evaluate the safety and efficacy of this treatment according to the prespecified protocol. Treatment-related adverse events included grade 3/4 cytokine release syndrome (CRS) in 17 patients (44.74%) and grade 4 immune effector cell-associated neurotoxicity syndrome (ICANS) in 1 patient (2.63%). Persistent cytopenia (all grades) was observed in all patients, with a median time to neutrophil recovery of 45 days. At a median follow-up of 24.87 months, the objective response rate (ORR) was 73.68% (28/38), and the minimal residual disease-negative complete response rate (MRD<sup>−</sup>CR) was 42.11%. Median progression-free survival (PFS) and overall survival (OS) were 9 months (95%CI 3.03–14.47) and 12.17 months (95%CI 3.03–24.87), respectively. The two-year PFS and OS rates were 47.94% (95%CI: 32.00%-63.83%) and 51.43% (95%CI 35.51%-67.32%), respectively. These results indicate a clinically relevant antitumor efficacy and a manageable safety profile of CLL1-targeted CAR-T cell therapy in adults with R/R AML.</p><p><?noindent??><b>Registry:</b>&#xa0;<a href="http://www.chictr.org.cn">www.chictr.org.cn</a>, TRN: ChiCTR2000041054, Registration date: 17 December 2020.</p>

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Updated data of CLL1 CAR-T cell therapy in adult patients with relapsed/refractory acute myeloid leukemia

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月18日

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  • Xiaomei Zhang,
  • Wenyi Lu,
  • Wenjun Zhang,
  • Xiaoyuan He,
  • Yu Zhang,
  • Xin Jin,
  • Meng Zhang,
  • Yingshuai Wang,
  • Xuwen Guan,
  • Rui Zhang,
  • Bing Wang,
  • Hairong Lyu,
  • Xia Xiao,
  • Xue Bai,
  • Yedi Pu,
  • Juanxia Meng,
  • Haibo Zhu,
  • Zhao Wang,
  • Huan Zhang,
  • Cuicui Lyu,
  • Hongkai Zhang,
  • Aibin Liang,
  • Mingfeng Zhao

摘要

CLL1-targeted chimeric antigen receptor T (CAR-T) cell therapy has shown clinically meaningful activity in relapsed/refractory acute myeloid leukemia (R/R AML). This updated phase I study enrolled 38 adults with R/R AML to evaluate the safety and efficacy of this treatment according to the prespecified protocol. Treatment-related adverse events included grade 3/4 cytokine release syndrome (CRS) in 17 patients (44.74%) and grade 4 immune effector cell-associated neurotoxicity syndrome (ICANS) in 1 patient (2.63%). Persistent cytopenia (all grades) was observed in all patients, with a median time to neutrophil recovery of 45 days. At a median follow-up of 24.87 months, the objective response rate (ORR) was 73.68% (28/38), and the minimal residual disease-negative complete response rate (MRD−CR) was 42.11%. Median progression-free survival (PFS) and overall survival (OS) were 9 months (95%CI 3.03–14.47) and 12.17 months (95%CI 3.03–24.87), respectively. The two-year PFS and OS rates were 47.94% (95%CI: 32.00%-63.83%) and 51.43% (95%CI 35.51%-67.32%), respectively. These results indicate a clinically relevant antitumor efficacy and a manageable safety profile of CLL1-targeted CAR-T cell therapy in adults with R/R AML.

Registry: www.chictr.org.cn, TRN: ChiCTR2000041054, Registration date: 17 December 2020.