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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004240-30 | EudraCT Number |
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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
| University of Regensburg | OTHER |
| Johannes Gutenberg University Mainz | OTHER |
| Charite University, Berlin, Germany |
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In patients after allogeneic stem cell transplantation reactivation of latent herpesviruses such as Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) is a frequent and life threatening complication requiring antiviral treatment. The underlying problem is a severe suppression of the donors immune system after transplantation into the patient. Herpesviruses such as CMV and EBV persist after primary infection life long in the host and therefore require constant immunological control. This control is largely provided by the T-cell compartment of the immune system. After allogeneic stem cell transplantation the T-cell compartment requires a long time for its reconstitution since only a small fraction of the donor T-cells are transplanted. During this time Herpesviruses can reoccur due to the lack of effective T-cell control.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adoptive transfer of CMV/EBV specific T-cells | Experimental | Repetitive adoptive T-cell transfer starting at day 30 after allogeneic stem cell transplantation. |
|
| Control | No Intervention | Observation only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMV/EBV specific T-cell | Biological | Peptide stimulated allogeneic T-cells with dual specificity for CMV and EBV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of adoptive transfer of CMV/EBV specific T-cells | Assessment of acute transfusion toxicity within 24 hours after adoptive T-cell transfer. Assessment of the development of acute transfusion associated acute graft versus host disease (GvHD) within 28 days after adoptive T-cell transfer | 1-28 days after adoptive T-cell transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of preventative/preemptive adoptive transfer of CMV/EBV specific T-cells on virus reactivation | Incidence of reactivation of CMV and/or EBV during the observation period assessed by virus specific PCR of peripheral blood. | During observation period until day 204 post transplantation |
| Influence of preventative/preemptive adoptive transfer of CMV/EBV specific T-cells on the use of antiviral therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armin H Gerbitz, MD, PhD | Charite University, Berlin, Germany | Study Director |
| Bernd Spriewald, MD, PhD | University Hospital Erlangen | Principal Investigator |
| Anita Kremer, MD,PhD | University Hospital Erlangen | Principal Investigator |
| Katja San Niccolo, MD | University Hospital Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Augsburg | Augsburg | 86156 | Germany | |||
| Charité University Hospital Berlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37965339 | Derived | 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. |
| Label | URL |
|---|---|
| Dept. of Medicine 5, Hematology/Oncology, University of Erlangen | View source |
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| OTHER |
| University Hospital Augsburg | OTHER |
| BayImmuNet Bavarian Immunotherapy Network | UNKNOWN |
| German Research Foundation | OTHER |
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Cumulative dose of Ganciclovir, Valganciclovir, Foscarnet, Cidofovir |
| During observation period until day 204 post transplantation |
| Influence of preventative/preemptive adoptive transfer of CMV/EBV specific T-cells on the use of Rituximab | Cumulative dose of Rituximab. | During observation period until day 204 post transplantation |
| Influence of preventative/preemptive adoptive transfer of CMV/EBV specific T-cells on T-cell reconstitution | Immunomonitoring of peripheral blood by flow cytometry. | During observation period until day 204 post transplantation |
| Berlin |
| 13353 |
| Germany |
| Universitiy Hospital Erlangen | Erlangen | 91054 | Germany |
| University of Mainz | Mainz | 55131 | Germany |
| University of Munich LMU | Munich | 81377 | Germany |
| University of Regensburg | Regensburg | 93053 | Germany |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
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