Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections
NCT ID: NCT04832607
Last Updated: 2025-07-18
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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RECRUITING
PHASE3
149 participants
INTERVENTIONAL
2019-08-27
2028-09-30
Brief Summary
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Detailed Description
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The standard treatment approach for viral infections/reactivations is chemotherapy which shows limited efficacy and does not restore immunity. Therefore, effective new treatment options are required for this condition.
Previous investigations have shown that sufficient T-cell immunity is essential for the control and prevention of viral reactivations and newly occurring infections after HSCT. The infusion of T-cells is therefore a promising new approach to treat immune-comprised patients. However, infusion with unselected T cells is associated with an increased risk for GvHD due to the high content of alloreactive T cells. A very promising approach to minimize this problem is to remove alloreactive T cells and enrich, isolate and purify virus-specific T cells.
This approach has been studied for nearly two decades and the data published up to date indicate that virus-specific T-cell responses after adoptive T-cell transfer protect against virus-related complications post HSCT and restore T-cell immunity, in particular for AdV-, CMV- and EBV-infections. Despite these promising results, virus-specific T-cell transfer is not yet translated into daily clinical practice due to the lack of prospective clinical trials confirming the efficacy of this treatment approach.
The overall goal of this Phase III, double-blind placebo-controlled study is to test efficacy of multivirus-specific T cells to bring this treatment method in clinical routine. Multivirus-specific T cells generated in this study will be directed against all three most common post-HSCT viral infections: AdV, CMV and EBV. Thus, T-cell immunity will be restored to fight and prevent new viral infections.
After an initial screening visit, patients eligible to participate in the study will be treated within 28 days after screening. Patients will be randomized in a 2:1 (treatment: placebo) ratio and receive a single infusion with either multivirus-specific T cells or placebo. Patients will be followed up on the day of treatment, 1 day after and 1, 2, 4, 8 and 15 weeks after treatment. Treatment success will be measured by assessing different parameters including symptoms, quality of life, viral load and T-cell immunity in blood samples.
Patients eligible to participate in this study are adult and paediatric patients who have received allogeneic stem cell transplantation and suffer from new or reactivated EBV, AdV or CMV infection refractory to standard antiviral treatment for two weeks. Patients from the six European countries Germany, Belgium, Netherlands, UK, France and Italy will be enrolled. In total 130 patients plus 19 screening failures are expected to participate in the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Multivirus (CMV, EBV, AdV)-specific T cells
Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of Cytomegalovirus, Adenovirus and Epstein-Barr Virus
Max dose:
* HLA-matched (8/8) donors: 1.0 x 10e5 T cells/kg recipient BW
* HLA-mismatched donors: 2.5 x 10e4 T cells/kg recipient BW
Min. dose:
\- 10 T cells/kg recipient BW
Multivirus (CMV, EBV, AdV)-specific T cells
Cell therapy product which is individually produced for each patient and administered via IV bolus injection.
Sodium chloride
Suspension of multivirus-specific T cells in 20 mL of 0.9% NaCl + 0.5% HSA
Multivirus (CMV, EBV, AdV)-specific T cells
Cell therapy product which is individually produced for each patient and administered via IV bolus injection.
Interventions
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Multivirus (CMV, EBV, AdV)-specific T cells
Cell therapy product which is individually produced for each patient and administered via IV bolus injection.
Eligibility Criteria
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Inclusion Criteria
2. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection.
3. Written informed consent given (patient or legal representative) prior to any study-related procedures.
Exclusion Criteria
2. Patient receiving steroids (\>1 mg/kg BW Prednisone equivalent) at Screening.
3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. Prescheduled prophylactic DLI ≤3x105 T cells/kg BW in case of T-cell depleted HSCT is not considered an exclusion criterion.
4. Patient with organ dysfunction or failure as determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30%
5. Concomitant enrolment in another clinical trial interfering with the endpoints of this study
6. Any medical condition which could compromise participation in the study according to the investigator's assessment
7. Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study
8. Second line or experimental antiviral treatment other than Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab until 8 weeks after IMP Infusion or prophylactic Treatment other than Aciclovir or Letermovir throughout the study except approved by sponsor
9. Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test.
10. Female patient who is pregnant or breast-feeding. Female patient of child-bearing potential (i.e. post menarche and not surgically sterilized) or male patient of reproductive potential not willing to use an effective method of birth control from Screening until the last follow-up visit (FU6, Visit 8).
Note: Women of childbearing potential must have a negative serum pregnancy test at study entry ≤7 days before IMP administration on Day 0. Acceptable birth control methods are hormonal oral contraceptive ('pill'), contraceptive injection or patch, intrauterine pessar or the combination of two barrier methods. The combination of female and male condomes is NOT acceptable. If the male partner is sterilized, no further contraceptive is required. Women of post-menopausal status (no menses for 12 months without an alternative medical cause) are also not required to use contraceptives during the study.
11. Known hypersensitivity to iron dextran
12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
2 Months
ALL
No
Sponsors
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European Commission
OTHER
Simbec-Orion Group Ltd, Merthyr Tydfil, UK
UNKNOWN
Miltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany
UNKNOWN
Leiden University Medical Center, LUMC, Leiden, The Netherlands
UNKNOWN
Central Hospital, Nancy, France
OTHER
Ghent University Hospital, UZG, Ghent, Belgium
UNKNOWN
Ospedale Pediatrico Bambino Gesù, OPBG, Rome, Italy
UNKNOWN
Newcastle University, UNEW, Newcastle, UK
UNKNOWN
Vall d'Hebron Institute of Oncology
OTHER
Tobias Feuchtinger
OTHER
Responsible Party
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Tobias Feuchtinger
Prof. Dr. med Tobias Feuchtinger
Principal Investigators
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Tobias Feuchtinger, Prof
Role: PRINCIPAL_INVESTIGATOR
Medical Center - University of Freiburg
Locations
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Institut Jules Bordet (JBI)
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
Ghent Universal Hospital (UZG)
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Université de Liège (ULG)
Liège, , Belgium
Hôpital Jeanne de Flandre, CHU Lille
Lille, , France
Institut d'Hématologie et Oncologie Pédiatrique (IHOPe)
Lyon, , France
Centre Hospitalier Régional Universitaire de Nancy (CHRU)
Nancy, , France
Hôpital de la Pitie-Salpêtrière
Paris, , France
Hôpital Necker - Enfants Malades
Paris, , France
Hôpital Robert Debré
Paris, , France
Charité Berlin (Campus Virchow-Klinikum) - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie
Berlin, , Germany
Universitätsklinikum Dresden
Dresden, , Germany
Universitätsklinikum Düsseldorf - Klinik für Kinder-Onkologie, -Hämatologie und klinische Immunologie
Düsseldorf, , Germany
Universitätsklinikum Essen - Pädiatrische Hämatologie-Onkologie
Essen, , Germany
Universitätsklinikum Freiburg - Klinik für Pädiatrische Hämatologie und Onkologie
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover - Zentrum für Kinderheilkunde und Jugendmedizin
Hanover, , Germany
Universitäsklinikum Leipzig - Medizinische Klinik und Poliklinik I
Leipzig, , Germany
LMU Klinikum - Dr. v. Haunersches Kinderspital
Munich, , Germany
Klinikum rechts der Isar der Technischen Universität - Kinderklinik Schwabing
Munich, , Germany
LMU Klinikum - Medizinische Klinik und Poliklinik III
München, , Germany
Klinikum rechts der Isar der Technischen Universität - Klinik und Poliklinik für Innere Medizin III
München, , Germany
Universitätsklinikum Regensburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Regensburg, , Germany
Universitätsklinikum Tübingen, Center for Pediatric Clinical Studies (CPCS)
Tübingen, , Germany
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II & Zentrum Innere Medizin (ZIM)
Würzburg, , Germany
Universitätsklinikum Würzburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Würzburg, , Germany
Ospedale Pediatrico Bambino Gesù (OPBG)
Rome, , Italy
Ospedale Infantile Regina Margherita - Oncoematologie Pediatrica
Turin, , Italy
Leiden University Medical Centre (LUMC) - Department of Hematology
Leiden, , Netherlands
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Hospital Universitario Politécnico La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-000853-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DRKS00018985
Identifier Type: OTHER
Identifier Source: secondary_id
TRACE
Identifier Type: -
Identifier Source: org_study_id
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