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  • Gerbitz, ArminUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany.;Princess Margaret Canc Ctr, Div Med Oncol Hematol, Toronto, ON, Canada. (author)

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

  • Article/chapterEnglish2023

Publisher, publication year, extent ...

  • Frontiers Media S.A.2023
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-519920
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-519920URI
  • https://doi.org/10.3389/fimmu.2023.1251593DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • IntroductionAllogeneic 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.MethodsWe 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.ResultsThirty-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.DiscussionOur 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 registrationhttps://clinicaltrials.gov, identifier NCT02227641.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Gary, ReginaUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Aigner, MichaelUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Moosmann, AndreasLMU Univ Hosp, Dept Med 3, Munich, Germany.;Helmholtz Ctr Munich, Inst Virol, Munich, Germany.;German Ctr Infect Res, Deutsch Zentrum Infektionsforsch DZIF, Munich, Germany. (author)
  • Kremer, AnitaUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Schmid, ChristophUniv Hosp Augsburg, Dept Med 2, Augsburg, Germany. (author)
  • Hirschbuehl, KlausUniv Hosp Augsburg, Dept Med 2, Augsburg, Germany. (author)
  • Wagner, EvaUniv Hosp Mainz, Dept Med 3, Mainz, Germany. (author)
  • Hauptrock, BeateUniv Hosp Mainz, Dept Med 3, Mainz, Germany. (author)
  • Teschner, DanielUniv Hosp Mainz, Dept Med 3, Mainz, Germany. (author)
  • Roesler, WolfUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Spriewald, BerndUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Tischer, JohannaLMU Univ Hosp, Dept Med 3, Munich, Germany. (author)
  • Moi, StephanieUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Balzer, HeidiUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Schaffer, StefanieUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Bausenwein, JudithUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Wagner, AnjaUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Schmidt, FranziskaUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Brestrich, JensCharite, Dept Hematol Oncol & Tumor Immunol, Berlin, Germany. (author)
  • Ullrich, BarbaraUniv Hosp Erlangen, Med Ctr Informat & Commun Technol, Erlangen, Germany. (author)
  • Maas, StefanieUniv Hosp Erlangen, Ctr Clin Studies CCS, Erlangen, Germany. (author)
  • Herold, SusanneUniv Hosp Erlangen, Ctr Clin Studies CCS, Erlangen, Germany. (author)
  • Strobel, JulianUniv Hosp Erlangen, Dept Transfus Med, Erlangen, Germany. (author)
  • Zimmermann, RobertUniv Hosp Erlangen, Dept Transfus Med, Erlangen, Germany. (author)
  • Weisbach, VolkerUniv Hosp Erlangen, Dept Transfus Med, Erlangen, Germany. (author)
  • Hansmann, LeoCharite, Dept Hematol Oncol & Tumor Immunol, Berlin, Germany. (author)
  • Lammoglia-Cobo, FernandaCharite, Dept Hematol Oncol & Tumor Immunol, Berlin, Germany. (author)
  • Remberger, Mats,Professor,1955-Uppsala universitet,Hematologi,Uppsala Univ Hosp, Clin Res & Dev Unit KFUE, Uppsala, Sweden.(Swepub:uu)matre804 (author)
  • Stelljes, MatthiasUniv Hosp Muenster, Dept Hematol Oncol, Munster, Germany. (author)
  • Ayuk, FrancisUniv Hosp Eppendorf, Dept Stem Cell Transplantat, Hamburg, Germany. (author)
  • Zeiser, RobertUniv Hosp Freiburg, Dept Med 1, Freiburg, Germany. (author)
  • Mackensen, AndreasUniv Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (author)
  • Univ Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany.;Princess Margaret Canc Ctr, Div Med Oncol Hematol, Toronto, ON, Canada.Univ Hosp Erlangen, Dept Med Hematol Oncol 5, Erlangen, Germany. (creator_code:org_t)

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  • In:Frontiers in Immunology: Frontiers Media S.A.141664-3224

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