Current research in translational medicine · 2025
Immunotherapy with ex vivo-expanded donor-derived NK cells after haploidentical HSCT in pediatric patients with AML: a phase I pilot study.
СтатьяКлиническое исследование I фазыНазвание и аннотация: Перевод пока не подготовлен
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Rostami Tahereh, Ahmadvand Mohammad, Chahardoli Bahram, Rostami Mohammad Reza, Azari Mojtaba, Azari Morteza, Kiumarsi Azadeh, Janbabaei Ghasem
Аннотация
BACKGROUND: Post-transplant relapse remains a considerable challenge for achieving successful outcomes in pediatric patients with acute myeloid leukemia (AML) receiving haploidentical hematopoietic stem cell transplantation (HSCT). Adoptive immune cell therapy strategies utilizing highly purified donor-derived natural killer (NK) cells have been extensively explored in various transplantation settings, demonstrating promise in preventing disease recurrence, especially in pediatric AML patients.
METHODS: Five pediatric and adolescent patients with high-risk AML were included in this pilot study and received haploidentical HSCT. On day 7 post-HSCT, all the patients received a single infusion of interleukin (IL)-2 stimulated ex vivo-expanded haploidentical NK cells (1 × 106/kg CD56+ cells of patient body weight).
RESULTS: All the patients tolerated the administration of NK cells without any adverse events during or after the infusion. Relapse occurred in two patients, both within the first 100 days post-transplantation, while three patients remained alive and disease-free one year post-transplantation.
CONCLUSION: This pilot study demonstrated that the activation, expansion, and infusion of NK cells from readily available haploidentical donors in pediatric and adolescent patients with high-risk AML after HSCT is safe and feasible.
METHODS: Five pediatric and adolescent patients with high-risk AML were included in this pilot study and received haploidentical HSCT. On day 7 post-HSCT, all the patients received a single infusion of interleukin (IL)-2 stimulated ex vivo-expanded haploidentical NK cells (1 × 106/kg CD56+ cells of patient body weight).
RESULTS: All the patients tolerated the administration of NK cells without any adverse events during or after the infusion. Relapse occurred in two patients, both within the first 100 days post-transplantation, while three patients remained alive and disease-free one year post-transplantation.
CONCLUSION: This pilot study demonstrated that the activation, expansion, and infusion of NK cells from readily available haploidentical donors in pediatric and adolescent patients with high-risk AML after HSCT is safe and feasible.