Actively Recruiting
Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections
Led by Tobias Feuchtinger · Updated on 2025-07-18
149
Participants Needed
33
Research Sites
470 weeks
Total Duration
On this page
Sponsors
T
Tobias Feuchtinger
Lead Sponsor
E
European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.
CONDITIONS
Official Title
Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 2 months who have undergone allogeneic stem cell transplantation, with no time limit since transplantation
- Patients suffering from new or reactivated CMV, EBV, or AdV infection that is refractory to standard antiviral treatment for at least two weeks, confirmed by blood PCR
- Original stem cell donor is available and has an immune response to the virus causing the infection
- Written informed consent obtained from patient or legal representative before any study procedures
You will not qualify if you...
- Patients with acute graft-versus-host disease greater than grade II or extensive chronic graft-versus-host disease at the time of treatment
- Patients receiving steroids at doses higher than 1 mg/kg Prednisone equivalent at screening
- Patients who received therapeutic donor lymphocyte infusion from 4 weeks before until 8 weeks after treatment
- Patients with organ dysfunction or failure with Karnofsky or Lansky score below 30%
- Patients enrolled in another clinical trial that interferes with study endpoints
- Any medical condition that could impair participation as judged by the investigator
- Progression of underlying disease limiting life expectancy to less than study duration
- Use of second-line or experimental antiviral treatments other than specified drugs until 8 weeks after treatment
- Known HIV infection or unknown HIV status without recent negative test
- Pregnant or breastfeeding females, or patients not willing to use effective birth control during study
- Known hypersensitivity to iron dextran
- Patients unable or unwilling to comply with the protocol or provide informed consent
AI-Screening
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Trial Site Locations
Total: 33 locations
1
Institut Jules Bordet (JBI)
Brussels, Belgium, 1000
Actively Recruiting
2
UZ Brussel
Brussels, Belgium, 1090
Actively Recruiting
3
Ghent Universal Hospital (UZG)
Ghent, Belgium, 9000
Actively Recruiting
4
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
5
Université de Liège (ULG)
Liège, Belgium, 4000
Actively Recruiting
6
Hôpital Jeanne de Flandre, CHU Lille
Lille, France, 59037
Actively Recruiting
7
Institut d'Hématologie et Oncologie Pédiatrique (IHOPe)
Lyon, France, 69008
Actively Recruiting
8
Centre Hospitalier Régional Universitaire de Nancy (CHRU)
Nancy, France, 54035
Actively Recruiting
9
Hôpital de la Pitie-Salpêtrière
Paris, France, 75013
Actively Recruiting
10
Hôpital Necker - Enfants Malades
Paris, France, 75015
Actively Recruiting
11
Hôpital Robert Debré
Paris, France, 75019
Actively Recruiting
12
Charité Berlin (Campus Virchow-Klinikum) - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie
Berlin, Germany, 13353
Actively Recruiting
13
Universitätsklinikum Dresden
Dresden, Germany, 01307
Actively Recruiting
14
Universitätsklinikum Düsseldorf - Klinik für Kinder-Onkologie, -Hämatologie und klinische Immunologie
Düsseldorf, Germany, 40225
Actively Recruiting
15
Universitätsklinikum Essen - Pädiatrische Hämatologie-Onkologie
Essen, Germany, 45147
Actively Recruiting
16
Universitätsklinikum Freiburg - Klinik für Pädiatrische Hämatologie und Onkologie
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
17
Medizinische Hochschule Hannover - Zentrum für Kinderheilkunde und Jugendmedizin
Hanover, Germany, 30625
Actively Recruiting
18
Universitäsklinikum Leipzig - Medizinische Klinik und Poliklinik I
Leipzig, Germany, 04103
Actively Recruiting
19
LMU Klinikum - Dr. v. Haunersches Kinderspital
Munich, Germany, 80337
Actively Recruiting
20
Klinikum rechts der Isar der Technischen Universität - Kinderklinik Schwabing
Munich, Germany, 80804
Actively Recruiting
21
LMU Klinikum - Medizinische Klinik und Poliklinik III
München, Germany, 81377
Actively Recruiting
22
Klinikum rechts der Isar der Technischen Universität - Klinik und Poliklinik für Innere Medizin III
München, Germany, 81675
Actively Recruiting
23
Universitätsklinikum Regensburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Regensburg, Germany, 93053
Actively Recruiting
24
Universitätsklinikum Tübingen, Center for Pediatric Clinical Studies (CPCS)
Tübingen, Germany, 72076
Actively Recruiting
25
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II & Zentrum Innere Medizin (ZIM)
Würzburg, Germany, 97080
Actively Recruiting
26
Universitätsklinikum Würzburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Würzburg, Germany, 97080
Actively Recruiting
27
Ospedale Pediatrico Bambino Gesù (OPBG)
Rome, Italy, 00165
Actively Recruiting
28
Ospedale Infantile Regina Margherita - Oncoematologie Pediatrica
Turin, Italy, 10126
Actively Recruiting
29
Leiden University Medical Centre (LUMC) - Department of Hematology
Leiden, Netherlands, 2333
Actively Recruiting
30
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain, 119-129
Actively Recruiting
31
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
32
Hospital Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
33
Hospital Universitario Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
T
Tobias Feuchtinger, Prof
CONTACT
T
Theresa Käuferle, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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