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Gerbitz, A.* ; Gary, R.* ; Aigner, M.* ; Moosmann, A. ; Kremer, A.* ; Schmid, C.* ; Hirschbuehl, K.* ; Wagner, E.* ; Hauptrock, B.* ; Teschner, D.* ; Roesler, W.* ; Spriewald, B.* ; Tischer, J.* ; Moi, S.* ; Balzer, H.* ; Schaffer, S.* ; Bausenwein, J.* ; Wagner, A.* ; Schmidt, F.* ; Brestrich, J.* ; Ullrich, B.* ; Maas, S.* ; Herold, S.* ; Strobel, J.* ; Zimmermann, R.* ; Weisbach, V.* ; Hansmann, L.* ; Lammoglia-Cobo, F.* ; Remberger, M.* ; Stelljes, M.* ; Ayuk, F.* ; Zeiser, R.* ; Mackensen, A.*

Prevention of CMV/EBV reactivation by double-specific T cells in patients after allogeneic stem cell transplantation: Results from the randomized phase I/IIa MULTIVIR-01 study.

Front. Immunol. 14:1251593 (2023)
Verlagsversion DOI PMC
Open Access Gold
Creative Commons Lizenzvertrag
INTRODUCTION: Allogeneic stem cell transplantation is used to cure hematologic malignancies or deficiencies of the hematopoietic system. It is associated with severe immunodeficiency of the host early after transplant and therefore early reactivation of latent herpesviruses such as CMV and EBV within the first 100 days are frequent. Small studies and case series indicated that application of herpes virus specific T cells can control and prevent disease in this patient population. METHODS: We report the results of a randomized controlled multi centre phase I/IIa study (MULTIVIR-01) using a newly developed T cell product with specificity for CMV and EBV derived from the allogeneic stem cell grafts used for transplantation. The study aimed at prevention and preemptive treatment of both viruses in patients after allogeneic stem cell transplantation targeting first infusion on day +30. Primary endpoints were acute transfusion reaction and acute-graft versus-host-disease after infusion of activated T cells. RESULTS: Thirty-three patients were screened and 9 patients were treated with a total of 25 doses of the T cell product. We show that central manufacturing can be achieved successfully under study conditions and the product can be applied without major side effects. Overall survival, transplant related mortality, cumulative incidence of graft versus host disease and number of severe adverse events were not different between treatment and control groups. Expansion of CMV/EBV specific T cells was observed in a fraction of patients, but overall there was no difference in virus reactivation. DISCUSSION: Our study results indicate peptide stimulated epitope specific T cells derived from stem cell grafts can be administered safely for prevention and preemptive treatment of reactivation without evidence for induction of acute graft versus host disease. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov, identifier NCT02227641.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Epstein-barr Virus Ebv ; Allogeneic ; Cytomegalovirus Cmv ; Epitope Specificity ; Prevention ; Reactivation ; Stem Cell Transplantation (sct); Epstein-barr-virus; Cytomegalovirus-infection; Responses; Lymphocytes; Cmv; Identification; Reconstitution; Immunotherapy; Expansion; Proteins
Sprache englisch
Veröffentlichungsjahr 2023
HGF-Berichtsjahr 2023
ISSN (print) / ISBN 1664-3224
e-ISSN 1664-3224
Zeitschrift Frontiers in Immunology
Quellenangaben Band: 14, Heft: , Seiten: , Artikelnummer: 1251593 Supplement: ,
Verlag Frontiers
Verlagsort Avenue Du Tribunal Federal 34, Lausanne, Ch-1015, Switzerland
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Virology (VIRO)
POF Topic(s) 30203 - Molecular Targets and Therapies
Forschungsfeld(er) Immune Response and Infection
PSP-Element(e) G-502700-001
Förderungen German Research Foundation
BayImmunet network of the Government of Bavaria
The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This work was supported by grants from the BayImmunet network of the Government of Bavaria and the German Research Foundation (SFB643).
DOI 10.3389/fimmu.2023.1251593
WOS ID 001100709100001
Scopus ID 85176435820
PubMed ID 37965339
Erfassungsdatum 2023-11-28
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