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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: AdV Infection, EBV Infection, CMV Infection, Stem Cell Transplant Complications

In brief

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.

Key facts

Study ID

NCT04832607

Run by

Tobias Feuchtinger

People needed

149

Starts

2019-08-27

Expected to finish

2028-09-01

Last updated by the study team

2025-07-18

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult or paediatric patients (> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection refractory to standard antiviral treatment for two weeks (defined as no decrease or insignificant decrease of less than 1log in viral load over two weeks) as confirmed by quantitative blood PCR analysis.
• Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection.
• Written informed consent given (patient or legal representative) prior to any study-related procedures.

You may not qualify if…

• Patient with acute GvHD > grade II or extensive chronic GvHD at the time of IMP transfer
• Patient receiving steroids (>1 mg/kg BW Prednisone equivalent) at Screening.
• 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.
• Patient with organ dysfunction or failure as determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30%
• Concomitant enrolment in another clinical trial interfering with the endpoints of this study
• Any medical condition which could compromise participation in the study according to the investigator's assessment
• 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
• 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
• 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.
• 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.
• Known hypersensitivity to iron dextran
• Patients unwilling or unable to comply with the protocol or unable to give informed consent.

Where it is running

• Institut Jules Bordet (JBI) — Brussels, Belgium (enrolling)
• UZ Brussel — Brussels, Belgium (enrolling)
• Ghent Universal Hospital (UZG) — Ghent, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Université de Liège (ULG) — Liège, Belgium (enrolling)
• Hôpital Jeanne de Flandre, CHU Lille — Lille, France (enrolling)
• Institut d'Hématologie et Oncologie Pédiatrique (IHOPe) — Lyon, France (enrolling)
• Centre Hospitalier Régional Universitaire de Nancy (CHRU) — Nancy, France (enrolling)
• Hôpital de la Pitie-Salpêtrière — Paris, France (enrolling)
• Hôpital Necker - Enfants Malades — Paris, France (enrolling)
• Hôpital Robert Debré — Paris, France (enrolling)
• Charité Berlin (Campus Virchow-Klinikum) - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie — Berlin, Germany (enrolling)
• Universitätsklinikum Dresden — Dresden, Germany (enrolling)
• Universitätsklinikum Düsseldorf - Klinik für Kinder-Onkologie, -Hämatologie und klinische Immunologie — Düsseldorf, Germany (enrolling)
• Universitätsklinikum Essen - Pädiatrische Hämatologie-Onkologie — Essen, Germany (enrolling)
• Universitätsklinikum Freiburg - Klinik für Pädiatrische Hämatologie und Onkologie — Freiburg im Breisgau, Germany (enrolling)
• Medizinische Hochschule Hannover - Zentrum für Kinderheilkunde und Jugendmedizin — Hanover, Germany (enrolling)
• Universitäsklinikum Leipzig - Medizinische Klinik und Poliklinik I — Leipzig, Germany (enrolling)
• LMU Klinikum - Dr. v. Haunersches Kinderspital — Munich, Germany (enrolling)
• Klinikum rechts der Isar der Technischen Universität - Kinderklinik Schwabing — Munich, Germany (enrolling)
• LMU Klinikum - Medizinische Klinik und Poliklinik III — München, Germany (enrolling)
• Klinikum rechts der Isar der Technischen Universität - Klinik und Poliklinik für Innere Medizin III — München, Germany (enrolling)
• Universitätsklinikum Regensburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation — Regensburg, Germany (enrolling)
• Universitätsklinikum Tübingen, Center for Pediatric Clinical Studies (CPCS) — Tübingen, Germany (enrolling)
• Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II & Zentrum Innere Medizin (ZIM) — Würzburg, Germany (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.