Results of phase 2 randomized multi-center study to evaluate the safety and efficacy of infusion of memory T cells as adoptive therapy in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia and/or lymphopenia (RELEASE NCT04578210).
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Ferreras Cristina, Hernández-Blanco Clara, Martín-Quirós Alejandro, Al-Akioui-Sanz Karima, Mora-Rillo Marta, Ibáñez Fátima, Díaz-Almirón Mariana, Cano-Ochando Jordi, Lozano-Ojalvo Daniel, Jiménez-González María, Goterris Rosa, Sánchez-Zapardiel Elena, de Paz Raquel, Guerra-García Pilar, Queiruga-Parada Javier, Molina Pablo, Briones María Luisa, Ruz-Caracuel Beatriz, Borobia Alberto M, Carcas Antonio J, Planelles Dolores, Vicario José Luis, Moreno Miguel Ángel, Balas Antonio, Llano Marta, Llorente Andrea, Del Balzo Álvaro, Cañada Carlos, García Miguel Ángel, Calvin María Elena, Arenas Isabel, Pérez de Diego Rebeca, Eguizábal Cristina, Soria Bernat, Solano Carlos, Pérez-Martínez Antonio
Аннотация
METHODS: Eighty-four patients were enrolled in three Spanish centers. The patients were randomized into the infusion of 1 × 106/kg CD45RA- memory T cells or the SoC. We selected four unvaccinated donors based on the expression of interferon gamma SARS-CoV-2-specific response within the CD45RA- memory T cells and the most frequent human leukocyte antigen typing in the Spanish population.
RESULTS: We analyzed data from 81 patients. The primary outcome for recovery, defined as the proportion of participants in each group with normalization of fever, oxygen saturation sustained for at least 24 hours and lymphopenia recovery through day 14 or at discharge, was met for the experimental arm. We also observed faster lymphocyte recovery in the experimental group. We did not observe any treatment-related adverse events.
CONCLUSIONS: Adoptive cell therapy with off-the-shelf CD45RA- memory T cells containing SAR-CoV-2-specific T cells is safe, effective and accelerates lymphocyte recovery of patients with COVID-19 pneumonia and/or lymphopenia.
TRIAL REGISTRATION: NCT04578210.