Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorTobias Feuchtinger
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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%
Trial design
Treatments tested in this trial
- Multivirus (CMV, EBV, AdV)-specific T cells
Treatment groups
149 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tobias Feuchtinger
Lead sponsor
University Hospital Freiburg
Sponsor institution
European Commission
Collaborator
Simbec-Orion Group Ltd, Merthyr Tydfil, UK
Collaborator
Miltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany
Collaborator
Leiden University Medical Center, LUMC, Leiden, The Netherlands
Collaborator
Central Hospital, Nancy, France
Collaborator
University Hospital, Ghent
Collaborator
Ospedale Pediatrico Bambino Gesù, OPBG, Rome, Italy
Collaborator
Newcastle University
Collaborator
Vall d'Hebron Institute of Oncology
Collaborator
Source ClinicalTrials.gov