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Deprecated: Implicit conversion from float 265.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 EClinicalMedicine 2021 ; 39 (ä): 101086 Nephropedia Template TP
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Phase I dose-escalation single centre clinical trial to evaluate the safety of infusion of memory T cells as adoptive therapy in COVID-19 (RELEASE) #MMPMID34405140
Perez-Martinez A; Mora-Rillo M; Ferreras C; Guerra-Garcia P; Pascual-Miguel B; Mestre-Duran C; Borobia AM; Carcas AJ; Queiruga-Parada J; Garcia I; Sanchez-Zapardiel E; Gasior M; De Paz R; Marcos A; Vicario JL; Balas A; Moreno MA; Eguizabal C; Solano C; Arribas JR; Buckley RM; Montejano R; Soria B
EClinicalMedicine 2021[Sep]; 39 (ä): 101086 PMID34405140show ga
BACKGROUND: Effective treatments are still needed to reduce the severity of symptoms, time of hospitalization, and mortality of COVID-19. SARS-CoV-2 specific memory T-lymphocytes obtained from convalescent donors recovered can be used as passive cell immunotherapy. METHODS: Between September and November 2020 a phase 1, dose-escalation, single centre clinical trial was conducted to evaluate the safety and feasibility of the infusion of CD45RA(-) memory T cells containing SARS-CoV-2 specific T cells as adoptive cell therapy against moderate/severe cases of COVID-19. Nine participants with pneumonia and/or lymphopenia and with at least one human leukocyte antigen (HLA) match with the donor were infused. The first three subjects received the lowest dose (1 x 10(5) cells/kg), the next three received the intermediate dose (5 x 10(5) cells/kg) and the last three received the highest dose (1 x 10(6) cells/kg) of CD45RA(-) memory T cells. Clinicaltrials.gov registration: NCT04578210. FINDINGS: All participants' clinical status measured by National Early Warning Score (NEWS) and 7-category point ordinal scales showed improvement six days after infusion. No serious adverse events were reported. Inflammatory parameters were stabilised post-infusion and the participants showed lymphocyte recovery two weeks after the procedure. Donor microchimerism was observed at least for three weeks after infusion in all patients. INTERPRETATION: This study provides preliminary evidence supporting the idea that treatment of COVID-19 patients with moderate/severe symptoms using convalescent CD45RA(-) memory T cells is feasible and safe. FUNDING: Clinical Trial supported by Spanish Clinical Research Network PT17/0017/0013. Co-funded by European Regional Development Fund/European Social Fund. CRIS CANCER Foundation Grant to AP-M and Agencia Valenciana de Innovacion Grant AVI-GVA COVID-19-68 to BS.