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).
CD45RA(−) memory T cells
COVID-19
cell therapy
immune recovery
lymphopenia
viral diseases
Journal
Cytotherapy
ISSN: 1477-2566
Titre abrégé: Cytotherapy
Pays: England
ID NLM: 100895309
Informations de publication
Date de publication:
29 Oct 2023
29 Oct 2023
Historique:
received:
11
06
2023
revised:
05
09
2023
accepted:
05
10
2023
pubmed:
29
10
2023
medline:
29
10
2023
entrez:
28
10
2023
Statut:
aheadofprint
Résumé
There are currently no effective anti-viral treatments for coronavirus disease 2019 (COVID-19)-hospitalized patients with hypoxemia. Lymphopenia is a biomarker of disease severity usually present in patients who are hospitalized. Approaches to increasing lymphocytes exerting an anti-viral effect must be considered to treat these patients. Following our phase 1 study, we performed a phase 2 randomized multicenter clinical trial in which we evaluated the efficacy of the infusion of allogeneic off-the-shelf CD45RA Eighty-four patients were enrolled in three Spanish centers. The patients were randomized into the infusion of 1 × 10 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. Adoptive cell therapy with off-the-shelf CD45RA NCT04578210.
Sections du résumé
BACKGROUND AIMS
OBJECTIVE
There are currently no effective anti-viral treatments for coronavirus disease 2019 (COVID-19)-hospitalized patients with hypoxemia. Lymphopenia is a biomarker of disease severity usually present in patients who are hospitalized. Approaches to increasing lymphocytes exerting an anti-viral effect must be considered to treat these patients. Following our phase 1 study, we performed a phase 2 randomized multicenter clinical trial in which we evaluated the efficacy of the infusion of allogeneic off-the-shelf CD45RA
METHODS
METHODS
Eighty-four patients were enrolled in three Spanish centers. The patients were randomized into the infusion of 1 × 10
RESULTS
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
CONCLUSIONS
Adoptive cell therapy with off-the-shelf CD45RA
TRIAL REGISTRATION
BACKGROUND
NCT04578210.
Identifiants
pubmed: 37897472
pii: S1465-3249(23)01056-3
doi: 10.1016/j.jcyt.2023.10.002
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04578210']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest CF, AP-M and BS filed patent PCT/EP2021/076516 on Memory T cells as adoptive cell therapy for viral diseases. All other authors have no commercial, proprietary or financial interest in the products or companies described in this article.