T cell-based products – CellGENTherapies

Virus-specific T cells

T cells trained to recognize and target cells infected with a particular virus

Manufacturing Process

For isolation of virus-specifc T cells from a leukapheresis product of a donor, we make use of the fully automated and closed CliniMACS Prodigy instrument (Miltenyi), which allows cell separation, centrifugation and cell culture. In brief, the cells of the leukapheresis product are incubated with virus antigens, after which the cytokine-secreting T cells are isolated by magnetic bead separation technique. The isolated T cells are adoptively transferred to the patient.

Quality control tests in place: sterility, mycoplasma, endotoxins, flow cytometry

Projects

TRACE

TRansfer of – Adenovirus, Cytomegalovirus and Epstein-Barr virus-specific T cells

Service: CellGENTherapies serves as one of the manufacturing sites for the TRACE study, with responsibility for the GMP-compliant production, quality control and release of the virus-specific T cell product.

Ongoing

TRACE is the first multi-national clinical phase-III trial to prove efficacy and safety of Adoptive T-cell transfer in immunocompromised individuals. The overall objective of the TRACE project is to bring Adoptive Transfer of virus-specific T cells into clinical routine.

In the TRACE study multivirus-specific (CMV, AdV and EBV-specific) T cells are isolated from blood of seropositive donors by an instrument called CliniMACS® Prodigy. The CliniMACS® Prodigy allows automated manufacturing of this T-cell product for adoptive T-cell therapy via the Cytokine Capture Technique and performs all steps in a functionally closed system.

Within T-cell product manufacture, the cellular starting material is incubated with specific Cytomegalovirus (CMV), Adenovirus (AdV) and Epstein-Barr virus (EBV) antigens. As a consequence, only the virus-specific T cells are induced to produce cytokines as they do under physiological conditions upon viral infection. These virus-specific, cytokine-secreting cells are labelled and conjugated to magnetic particles for the following enrichment using a magnetic column.