期刊
BRITISH JOURNAL OF HAEMATOLOGY
卷 195, 期 5, 页码 710-721出版社
WILEY
DOI: 10.1111/bjh.17751
关键词
R; R AML; NK cell; adoptive immunotherapy; CNS leukaemia
类别
资金
- MCTI/CNPQ/MS-SCTIE - DECIT (Ministerio da Ciencia, Tecnologia e Inovacao e Comunicacoes/ Conselho Nacional de Pesquisa/Ministerio da Saude-Secretaria de Ciencia, Tecnologia e Insumos Estrategicos- Departamento de Ciencia e Tecnologia) [401193/2013-6]
- MS/DECIT/MCTI/FINEP (Ministerio da Saude/Departamento de Ciencia e Tecnologia/ Ministerio da Ciencia, Tecnologia e Inovacao e Comunicacoes/Financiadora de Estudos e Projetos) [01.08.0630.01]
- MEC/CAPES/PRODOC (Ministerio da Educacao/Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior/Programa de Desenvolvimento Profissional e Formacao Pedagogica Docente) [23038.004681/2014-17]
- CGSAU 2012 (APQ) (Coordenacao do Programa de Pesquisa em Saude) [404896/2012-0]
- GESCON (Sistema de Gestao de Consultas e Normas) [375/2013]
- MS/FNS/MCTI/CNPQ (Ministerio da Saude/Fundo Nacinal de Saude) [455405/2014-0]
- MEC/MCTI/CAPES/CNPQ/FAPS (Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior/Ministerio da Ciencia, Tecnologia e Inovacao e Comunicacoes/Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior/Conselho Nacional de Pesquisa/Fundacao de Apoio a [401086/2014-3]
- FIPE - HCPA (Fundo de Pesquisa - Hospital de Clinicas de Porto Alegre) [10-0457]
- Brazilian Public Health System (SUS - Sistema Unico de Saude)
- Kiadis Pharma
In this study, repeated infusions of expanded NK cells showed promising outcomes in high-risk patients with relapsed or refractory AML, with high overall response and complete response rates. No dose-limiting toxicities or infusion-related complications were observed, indicating the safety and feasibility of this treatment approach.
Patients with acute myeloid leukaemia (AML) have a five-year survival rate of 28 center dot 7%. Natural killer (NK)-cell have anti-leukaemic activity. Here, we report on a series of 13 patients with high-risk R/R AML, treated with repeated infusions of double-bright (CD56(bright)/CD16(bright)) expanded NK cells at an academic centre in Brazil. NK cells from HLA-haploidentical donors were expanded using K562 feeder cells, modified to express membrane-bound interleukin-21. Patients received FLAG, after which cryopreserved NK cells were thawed and infused thrice weekly for six infusions in three dose cohorts (10(6)-10(7) cells/kg/infusion). Primary objectives were safety and feasibility. Secondary endpoints included overall response (OR) and complete response (CR) rates at 28-30 days after the first infusion. Patients received a median of five prior lines of therapy, seven with intermediate or adverse cytogenetics, three with concurrent central nervous system (CNS) leukaemia, and one with concurrent CNS mycetoma. No dose-limiting toxicities, infusion-related fever, or cytokine release syndrome were observed. An OR of 78 center dot 6% and CR of 50 center dot 0% were observed, including responses in three patients with CNS disease and clearance of a CNS mycetoma. Multiple infusions of expanded, cryopreserved NK cells were safely administered after intensive chemotherapy in high-risk patients with R/R AML and demonstrated encouraging outcomes.
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