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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Multivirus (CMV, EBV, AdV)-specific T cells
Other interventionCell therapy product which is individually produced for each patient and administered via IV bolus injection.
Treatment groups
149 Participants
are divided into 2 treatment groupsGroup A: Multivirus (CMV, EBV, AdV)-specific T cellsExperimental treatment 1 intervention
Group B: Sodium chloridePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Viral clearance
Percentage of patients with viral clearance (defined as two consecutive negative PCRs) to determine efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after allogeneic stem cell transplantation
Time frame
8 weeks after treatment2
Disease Progression
Percentage of patients with progression between Day 7 and Week 8 after T-cell Transfer to determine efficacy of multispecific T-cell transfer in patients with chemo-refractory viral infections after allogeneic stem cell transplantation
Time frame
day 7 until week 8 after treatmentSecondary outcomes
1
Incidence of acute GvHD
Incidence of newly occurring acute GvHD grade I from Day 0 to Week 8 and Week 15.
Time frame
15 weeks after treatment2
Incidence of chronic GvHD
Incidence of chronic GvHD from Day 7 to Week 8 and to Week 15 after treatment.
Time frame
15 weeks after treatment3
Time to newly occuring GvHD
Time to newly occurring acute and chronic GvHD.
Time frame
15 weeks after treatment4
Severity of GvHD
Severity of acute GvHD ≥ grade II until Week 8 and Week 15.
Time frame
week 8 and 15 week after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
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