Multivirus (CMV, EBV, AdV)-specific T cells: Cell therapy product which is individually produced for each patient and administered via IV bolus injection.
Study 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
Sex
ALL
Min age
2 Months
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection.
3. Written informed consent given (patient or legal representative) prior to any study-related procedures.
Exclusion Criteria:
1. Patient with acute GvHD \> grade II or extensive chronic GvHD at the time of IMP transfer
2. Patient receiving steroids (\>1 mg/kg BW Prednisone equivalent) at Screening.
3. 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.
4. Patient with organ dysfunction or failure as determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30%
5. Concomitant enrolment in another clinical trial interfering with the endpoints of this study
6. Any medical condition which could compromise participation in the study according to the investigator's assessment
7. 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
8. 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
9. 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.
10. 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.
11. Known hypersensitivity to iron dextran
12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
Primary outcome measure(s)
Viral clearance — 8 weeks after treatment 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
Disease Progression — day 7 until week 8 after treatment 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
Trial sites (33)
Facility
City
Region
Status
Institut Jules Bordet (JBI)
Brussels
Belgium
Recruiting
UZ Brussel
Brussels
Belgium
Recruiting
Ghent Universal Hospital (UZG)
Ghent
Belgium
Recruiting
UZ Leuven
Leuven
Belgium
Recruiting
Université de Liège (ULG)
Liège
Belgium
Recruiting
Hôpital Jeanne de Flandre, CHU Lille
Lille
France
Recruiting
Institut d'Hématologie et Oncologie Pédiatrique (IHOPe)
Lyon
France
Recruiting
Centre Hospitalier Régional Universitaire de Nancy (CHRU)
Nancy
France
Recruiting
Hôpital de la Pitie-Salpêtrière
Paris
France
Recruiting
Hôpital Necker - Enfants Malades
Paris
France
Recruiting
Hôpital Robert Debré
Paris
France
Recruiting
Charité Berlin (Campus Virchow-Klinikum) - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie
Berlin
Germany
Recruiting
Universitätsklinikum Dresden
Dresden
Germany
Recruiting
Universitätsklinikum Düsseldorf - Klinik für Kinder-Onkologie, -Hämatologie und klinische Immunologie
Universitätsklinikum Freiburg - Klinik für Pädiatrische Hämatologie und Onkologie
Freiburg im Breisgau
Germany
Recruiting
Medizinische Hochschule Hannover - Zentrum für Kinderheilkunde und Jugendmedizin
Hanover
Germany
Recruiting
Universitäsklinikum Leipzig - Medizinische Klinik und Poliklinik I
Leipzig
Germany
Recruiting
LMU Klinikum - Dr. v. Haunersches Kinderspital
Munich
Germany
Recruiting
Klinikum rechts der Isar der Technischen Universität - Kinderklinik Schwabing
Munich
Germany
Recruiting
LMU Klinikum - Medizinische Klinik und Poliklinik III
München
Germany
Recruiting
Klinikum rechts der Isar der Technischen Universität - Klinik und Poliklinik für Innere Medizin III
München
Germany
Recruiting
Universitätsklinikum Regensburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Regensburg
Germany
Recruiting
Universitätsklinikum Tübingen, Center for Pediatric Clinical Studies (CPCS)
Tübingen
Germany
Recruiting
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II & Zentrum Innere Medizin (ZIM)
Würzburg
Germany
Recruiting
Universitätsklinikum Würzburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Würzburg
Germany
Recruiting
Ospedale Pediatrico Bambino Gesù (OPBG)
Rome
Italy
Recruiting
Ospedale Infantile Regina Margherita - Oncoematologie Pediatrica
Turin
Italy
Recruiting
Leiden University Medical Centre (LUMC) - Department of Hematology
Leiden
Netherlands
Recruiting
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona
Spain
Recruiting
Hospital Universitario La Paz
Madrid
Spain
Recruiting
Hospital Virgen del Rocío
Seville
Spain
Recruiting
Hospital Universitario Politécnico La Fe
Valencia
Spain
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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