Actively Recruiting
Treatment of Chemo-refractory Viral Infections After Allogeneic Stem Cell Transplantation With Multispecific T Cells Against CMV, EBV and AdV: A Phase III, Prospective, Multicentre Clinical Trial
Led by Tobias Feuchtinger · Updated on 2025-07-18
149
Participants Needed
33
Research Sites
26 weeks
Total Duration
On this page
Sponsors
T
Tobias Feuchtinger
Lead Sponsor
E
European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates the use of multivirus-specific T-cell transfer to treat children and adults who have undergone allogeneic stem cell transplantation (HSCT) and suffer from new or reactivated infections caused by Cytomegalovirus (CMV), Epstein-Barr virus (EBV), or Adenovirus (AdV). These viral infections are significant complications after HSCT due to the weakened immune system from the transplantation and its preparative treatments. The study aims to confirm the effectiveness of this treatment in restoring protective T-cell immunity against these infections. Participants will be randomly assigned in a 2:1 ratio to receive either a single infusion of multivirus-specific T cells or a placebo. The T cells are prepared to target the three viruses CMV, EBV, and AdV, with dosing based on donor matching and recipient body weight. The study begins with a screening visit, followed by treatment within 28 days. Patients will be monitored on the day of infusion and at multiple intervals up to 15 weeks after treatment. Throughout the study, participants will undergo assessments including viral load measurements, symptom evaluation, quality of life questionnaires, and immune monitoring through blood samples. Researchers will track viral clearance, disease progression, graft-versus-host disease (GvHD), toxicity, and overall survival. Safety and treatment effects will be closely monitored during the follow-up visits, which extend up to 15 weeks post-treatment.
CONDITIONS
Brief 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 older than 2 months who have received allogeneic stem cell transplantation
- New or reactivated CMV, EBV, or AdV infection not responding to standard antiviral treatment for at least two weeks
- Original stem cell donor available with immune response to the virus causing the infection
- Written informed consent provided by patient or legal representative
You will not qualify if you...
- Acute graft-versus-host disease greater than grade II or extensive chronic graft-versus-host disease at treatment time
- Receiving steroids over 1 mg/kg Prednisone equivalent at screening
- Therapeutic donor lymphocyte infusion within 4 weeks before or 8 weeks after treatment
- Organ dysfunction or failure with Karnofsky or Lansky score 30% or less
- Participation in another conflicting clinical trial
- Medical conditions compromising study participation
- Progression of underlying disease limiting life expectancy below study duration
- Use of second line or experimental antiviral treatments outside approved medications
- Known HIV infection without recent negative test
- Pregnant or breastfeeding females, or those and males unwilling to use effective birth control
- Known hypersensitivity to iron dextran
- Inability or unwillingness to comply with protocol or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 28 days after screening
Participants receive a single infusion of either multivirus-specific T cells or placebo to treat viral infections after stem cell transplantation.
1 infusion visit (in-person)
Duration - 15 weeks after treatment
Participants are monitored for treatment effects, symptoms, viral load, and immune response after the infusion.
7 visits (in-person) including day of treatment, 1 day after, and weeks 1, 2, 4, 8, and 15
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
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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
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10
Hôpital Necker - Enfants Malades
Paris, France, 75015
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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
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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
T
Theresa Käuferle, Dr
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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