Preventative/Preemptive Adoptive Transfer of Peptide Stimulated CMV/EBV Specific T-cells in Patients After Allogeneic Stem Cell Transplantation
NCT ID: NCT02227641
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2014-10-31
2017-03-31
Brief Summary
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This study therefore aims at reconstituting the T-cell compartment with CMV and EBV specific T-cells at an early time point after allogeneic stem cell transplantation. It is mainly a phase I study to demonstrate that these in vitro generated T-cells can be applied safely in this patient population. The study also aims at demonstrating the efficacy of CMV/EBV specific T-cells by monitoring viral reactivation and use of antiviral drugs. The hypothesis is, that CMV/EBV specific T-cell can be applied safely and do not result in graft versus host disease and that they successfully prevent reactivation of CMV and EBV after adoptive transfer in patients after allogeneic stem cell transplantation.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Adoptive transfer of CMV/EBV specific T-cells
Repetitive adoptive T-cell transfer starting at day 30 after allogeneic stem cell transplantation.
CMV/EBV specific T-cell
Peptide stimulated allogeneic T-cells with dual specificity for CMV and EBV
Control
Observation only.
No interventions assigned to this group
Interventions
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CMV/EBV specific T-cell
Peptide stimulated allogeneic T-cells with dual specificity for CMV and EBV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HLA identical donor, related or unrelated, 10/10 match
* Stem cell source: G-SCF mobilized peripheral blood stem cells
* Presence of at least one HLA allele: A0101, A0201, B0702, B0801, B3501, C0702
* Positive EBV serology of the donor
* Positive CMV serology of the donor
* Adequate contraception
Exclusion Criteria
* Donor EBV seronegative
* Stem cell source: bone marrow or cord blood
* Alemtuzumab for conditioning
* Sorror Score \>3
* Pregnancy
18 Years
75 Years
ALL
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
University of Regensburg
OTHER
Johannes Gutenberg University Mainz
OTHER
Charite University, Berlin, Germany
OTHER
University Hospital Augsburg
OTHER
BayImmuNet Bavarian Immunotherapy Network
UNKNOWN
German Research Foundation
OTHER
University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Armin H Gerbitz, MD, PhD
Role: STUDY_DIRECTOR
Charite University, Berlin, Germany
Bernd Spriewald, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Erlangen
Anita Kremer, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Erlangen
Katja San Niccolo, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Erlangen
Locations
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Medical Center Augsburg
Augsburg, , Germany
Charité University Hospital Berlin
Berlin, , Germany
Universitiy Hospital Erlangen
Erlangen, , Germany
University of Mainz
Mainz, , Germany
University of Munich LMU
Munich, , Germany
University of Regensburg
Regensburg, , Germany
Countries
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References
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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. 2023 Oct 30;14:1251593. doi: 10.3389/fimmu.2023.1251593. eCollection 2023.
Related Links
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Dept. of Medicine 5, Hematology/Oncology, University of Erlangen
Other Identifiers
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2012-004240-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AIT-MULTIVIR-01
Identifier Type: -
Identifier Source: org_study_id