dm+d

Unassigned

New Medicines

Cytovir CMVCytomegalovirus infections; prevention of CMV reactivation following allogeneic haematopoietic stem cell transplantation from sibling or unrelated donor

Information

Cytovir CMV
Cell-based therapy (not an ATMP)
Cell Medica
Cell Medica

Development and Regulatory status

Phase III Clinical Trials
None
None
01. Oct 15: Cytovir CMV is available to treat patients by request (UK only) [2].
02. Oct 15: In the UK, Cytovir CMV is defined as a Cellular Therapy Product that does not fall under the definition of a medicinal product. As such, it is not subject to the licensing process relevant to Advanced Therapy Medicinal Products described in Directive 2001/83/EC and amending Regulations. Neither safety nor efficacy have therefore been established to the level that would be expected for a medicinal product [2].

Category

A CMV-specific T cell-based therapy. CMV-specific memory T cells can be recovered from a donor and infused into the patient to reconstitute immediate and long-lasting immunity against CMV infection.
It is estimated that 50-80% of adults in the UK are infected with CMV. In an allogeneic HSCT patient who is CMV seropositive or receiving a transplant from a donor who is CMV seropositive, CMV frequently reactivates and the disease resulting from the progression of infection is a major cause of infectious morbidity and mortality. In 2013, 1,602 patients underwent allogeneic haematopoietic stem cell transplantation in the UK.
Cytomegalovirus infections; prevention of CMV reactivation following allogeneic haematopoietic stem cell transplantation from sibling or unrelated donor
Intravenous infusion

Trial or other data

01. Sep 08: PIII CMV-IMPACT trial begins (NCT01077908). The trial is the first confirmatory study aimed at assessing the comparative efficacy of adoptive cell therapy, relative to conventional antiviral drug treatment, for CMV infections. The trial will assess efficacy of Cytovir in preventing reactivation episodes of CMV infections following an allogeneic haematopoietic stem cell (bone marrow) transplant. Patients will be divided into three treatment groups: best available antiviral drug treatment (AVDT); gamma catch-selected T cells + AVDT; and multimer-selected T cells + AVDT [1].
02. Jul 13: Cell Medica completes a PII trial of its CMV-specific T cell therapy for pre-emptive treatment of CMV infections in the UK (CMV-ACE/ASPECT; NCT01220895). This trial was adapted from the earlier CMV-ACE study (NCT00986557), which planned to investigate the therapy from both sibling donors and unrelated donors. However, the latter trial evaluated the treatment in 36 patients who received bone marrow transplants from unrelated donors. The primary endpoint was the peak number of circulating CMV-reactive T cells within the first two months, after single positive CMV PCR result [1].
03. Oct 14: CMV-IMPACT trial completes; it enrolled approximately 91 patients in the UK. The trial was funded by the Wellcome Trust through a Translation Award to Cell Medica [1].
04. Oct 15: In the PI/II ASPIRE trial, Cytovir CMV was administered at 1x104 CD3+ T cells/kg as a single dose to paediatric patients [3].

Evidence based evaluations

23 February 2016NIHR