Tests virus-fighting T cells for viral infections after stem cell transplant
Tests virus-fighting T cells in children and adults with viral infections after stem cell transplant.
Plain-language title generated from the registry record
Registry title: Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections
Key facts
- Where
- Lille Cedex, Paris, and Vandoeuvre Les Nancy, FranceSee the 4 sites
- Phase
- Phase 3
Where in France
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Hopitaux Universitaires Pitie SalpetriereParis, FranceTaking people
- Robert Debre University HospitalParis, FranceTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Tobias Feuchtinger
- Trial code
- NCT04832607EU 2024-512321-84-00
- Record updated
- 18 July 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Patient receiving steroids (>1 mg/kg BW Prednisone equivalent) at Screening; 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; Known hypersensitivity to iron dextran; 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; 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; Patient with organ dysfunction or failure as determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30%; Patient with acute GvHD > grade II or extensive chronic GvHD at the time of IMP transfer; 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; Patients unwilling or unable to comply with the protocol or unable to give informed consent.