RecruitingPhase 3NCT04832607

Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections

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

Sponsor

Tobias Feuchtinger

Enrollment

149 participants

Start Date

Aug 27, 2019

Study Type

INTERVENTIONAL

Conditions

Stem Cell Transplant Complications EBV Infection CMV Infection AdV Infection

Summary

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.

Eligibility

Min Age: 2 Months

Plain Language Summary

Simplified for easier understanding

This study tests a treatment for patients who have received a stem cell transplant and then develop a serious viral infection — specifically cytomegalovirus (CMV), Epstein-Barr virus (EBV), or adenovirus (AdV) — that is not responding to standard antiviral drugs. The treatment involves transferring immune T-cells from the original stem cell donor to the patient, giving the patient's immune system a boost from cells that already know how to fight the specific virus. Stem cell transplant recipients are at high risk for these viral infections because their immune systems are suppressed. When antiviral drugs stop working, this virus-specific T-cell transfer (VST) approach offers a targeted and potentially life-saving alternative. Participants of any age — from infants over 2 months to adults — are eligible if they meet the criteria. You may be eligible if: - You are over 2 months of age and have had an allogeneic stem cell transplant - You have a confirmed CMV, EBV, or adenovirus infection that has not responded to standard antiviral treatment for 2 weeks - Your original stem cell donor is available and has an immune response to the relevant virus You may NOT be eligible if: - You have active severe graft-versus-host disease (GvHD grade >II or extensive chronic GvHD) - You are receiving high-dose steroids (more than 1 mg/kg prednisone) - You are pregnant or breastfeeding - You are known to be HIV positive - You are currently enrolled in another interfering clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMultivirus (CMV, EBV, AdV)-specific T cells

Cell therapy product which is individually produced for each patient and administered via IV bolus injection.

Locations(33)

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

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NCT04832607

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