The phase I RELEASE clinical trial to evaluate the safety of NK cells in COVID-19

评估 NK 细胞在 COVID-19 中的安全性的 I 期 RELEASE 临床试验

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作者:Clara Hernández-Blanco, Karima Al-Akioui-Sanz, Lara Herrera, Cristina Aguirre-Portolés, Daniel Lozano-Ojalvo, Leticia Pérez-Rodriguez, Jordi Cano-Ochando, Pilar Guerra-García, Alejandro Martín-Quirós, José Luis Vicario, Silvia Santos, Miguel Ángel Pérez-Vaquero, Miguel Ángel Vesga, Alberto M Borobia

Abstract

The severity of COVID 19 symptoms has a direct correlation with lymphopenia, affecting natural killer (NK) cells. SARS-CoV-2 specific "memory" NK cells obtained from convalescent donors can be used as cell immunotherapy. In 2022 a phase I, dose-escalation, single center clinical trial was conducted to evaluate the safety and feasibility of the infusion of CD3-/CD56+ NK cells against moderate/severe cases of COVID-19 (NCT04578210). Six participants with pneumonia and/or lymphopenia were infused. Four patients received a single-dose infusion of NK cells of 1×106/kg, and the following two patients a dose of 2×106/kg of NK cells. All participants' clinical status and inflammation markers were monitored. No serious adverse events were reported after infusion. Exploratory outcomes included the donor chimerism, NK-cell immunophenotype evolution, and immune lymphocyte reconstitution. This study provides preliminary evidence supporting the idea that treatment of COVID-19 patients with moderate/severe symptoms using NK from COVID-19 convalescent donors is feasible and safe.

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