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

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.

Conditions

• AdV Infection
• EBV Infection
• CMV Infection
• Stem Cell Transplant Complications

Interventions

OTHER

Multivirus (CMV, EBV, AdV)-specific T cells

Cell therapy product which is individually produced for each patient and administered via IV bolus injection.

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• Simbec-Orion Group Ltd, Merthyr Tydfil, UK

  collaborator UNKNOWN

• Miltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany

  collaborator UNKNOWN

• Leiden University Medical Center, LUMC, Leiden, The Netherlands

  collaborator UNKNOWN

• Central Hospital, Nancy, France

  collaborator OTHER

• Ghent University Hospital, UZG, Ghent, Belgium

  collaborator UNKNOWN

• Ospedale Pediatrico Bambino Gesù, OPBG, Rome, Italy

  collaborator UNKNOWN

• Newcastle University, UNEW, Newcastle, UK

  collaborator UNKNOWN

• Vall d'Hebron Institute of Oncology

  collaborator OTHER

• Tobias Feuchtinger

  lead OTHER

Principal Investigators

• Tobias Feuchtinger, Prof · Medical Center - University of Freiburg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-27

Primary Completion

2028-03-31

Completion

2028-09-30

Countries

• Belgium
• France
• Germany
• Italy
• Netherlands
• Spain

Study Locations