VHIO and Catalan Blood & Tissue Bank trial to assess novel T-cell therapy

VHIO and the Catalan Blood & Tissue Bank launch first clinical trial with antiviral T-cell therapy developed entirely in Spain
Cytomegalovirus (CMV) is the most common viral infection affecting bone marrow transplant patients
The REDOCEL donor registry, a unique undertaking in Spain, has been established to accelerate the development of this novel approach

Officially announced today, VHIO and the Catalan Blood and Tissue Bank (Banc de Sang i Teixits – BST), in collaboration with the Hospital La Fe in Valencia and other Catalonia-based hospitals, have co-launched a clinical trial to evaluate the safety and efficacy of a novel T-cell therapy –ViroTCell- consisting of specific allogenic T-cells selected from donors for the treatment of cytomegalovirus (CMV) infections. More specifically, this approach is being developed for patients with treatment-resistant infections or for those who are unable to tolerate other medicines.

This study is the first of its kind with antiviral T-cell therapy developed in Spain and is co-led by Pere Barba, Hematologist and Clinical Investigator of VHIO’s Experimental Hematology Group, directed by Francesc Bosch. Pere will lead the clinical development of the trial, in collaboration with Sergi Querol, Director of the Catalan Blood and Tissue Bank’s Department of Cell Therapy, who is responsible for the production of these cells, as well as Guillermo Sanz from the Hospital La Fe.

ViroTCell will be administered to patients treated at the Vall d’Hebron University Hospital’s (Vall d’Hebron Barcelona Hospital Campus) recently inaugurated Advanced Cell Therapy Unit. Supported by the Fundación Vila Casas, this Unit is the first facility in Spain that is exclusively focused on novel cell-based therapies against cancer and is particularly dedicated to advancing the treatment and care of patients suffering from blood and lymph node cancers

Effectively treating CMV in hematopoietic cell transplant recipients is crucial since the pathogenesis of these infections and disease is complex with several interactions between CMV and the immune system. Infections can therefore cause serious complications in patients with compromised immune systems. Commenting for VHIO Communications Pere Barba observed, “Up to 95% of transplant patients with CMV infections are cancer patients, representing one of the most common complications associated with stem cell transplantation.”

Cytomegalovirus (CMV) is related to the viruses that cause chickenpox and mononucleosis. Once it takes hold, the body retains the virus for life. “Between fifty and eighty per cent of the global population carry this virus, although most people with CMV who are otherwise healthy experience few, if any, signs or symptoms and will never suffer from an associated complication. However, in individuals with weakened immune systems, such as immunosuppressed patients, this ‘sleeping’ virus can be reactivated and result in serious and even fatal consequences,” added Pere.

Such is the case for patients who undergo stem cell transplants for the treatment of hematological tumors. Antiviral therapies including ganciclovir and foscarnet are indicated for CMV infections with relatively satisfactory results. However, options for patients who subsequently either develop resistance to these agents or are unable to tolerate related toxicities remain extremely limited. Up until now, that is.

ViroTCell, a novel cell-based therapy with specific allogenic T-cells, shows promise in providing fresh hope for these individuals. This present clinical study, with patient enrolment totaling at 20, aims to validate VitroTCell’s safety and efficacy in re-triggering an immune response against CMV. Prospective studies will also focus on specific T-cells by chimerism analysis, as well as the time it takes to identify donors. Given that providing this type of cell therapy relies on rapid administration, the latter is of utmost importance. While CMV-Specific T-cells normally derive from family member donors, certain patients either have relatives with insufficient concentrations of lymphocytes, or no relative at all. Alternative donors must therefore be identified, and quickly.

To respond to this critical need, the Catalan Blood and Tissue Bank has established the REDOCEL registry, the only one of its kind in Spain and one among a handful across Europe. Set up in collaboration with the Valencian Transfusion Center, this facility comprises regular and voluntary blood donors who are also eligible to donate these cells. This vital resource will therefore help to reduce timelines and render this cell-based therapy more readily available once clinical studies have concluded.

This project has been funded by the Spanish Ministry of Science, Innovation and Universities, and supported by the Blood and Tissue Bank resources as promoter of the study.