Cell Medica: Research

Cytovir CMV

CMV~IMPACT Trial

Cytomegalovirus ~ ImmunoProphylactic Adoptive Cellular Therapy Study

Overview

The CMV~IMPACT trial is a phase III randomised study to investigate the use of adoptive cellular therapy (Cytovir CMV) in combination with conventional antiviral drug therapy for the treatment of CMV reactivation episodes in patients following allogeneic haematopoietic stem cell transplant from a seropositive sibling donor.

CMV~IMPACT is designed to meet a target of 95 patients (with a minimum of 70 required), where patients will be assigned to receive Cytovir CMV in combination with standard antiviral treatment and compared to those receiving standard antiviral treatment alone.

The Principal Investigator for this study is Dr Karl Peggs, Senior Lecturer and Consultant in Stem Cell Transplantation and Immunotherapy at UCL Cancer Institute.

The study is due for completion by mid 2013.

View CMV~IMPACT on ClinicalTrials.gov

The study is funded through a Translation Award by the Wellcome Trust.

Centres

The study is recruiting at 14 centres across the UK.

  • Addenbrookes Hosp., Cambridge
  • The Beatson West of Scotland Cancer Centre, Glasgow
  • Birmingham Heartlands Hosp.
  • Bristol Children’s Hosp.
  • The Christie, Manchester
  • King’s College Hosp., London
  • Manchester Royal Infirmary
  • Nottingham University Hosp.
  • Queen Elizabeth Hosp., Birmingham
  • The Royal Free Hosp., London
  • The Royal Hosp. Liverpool
  • Southampton General Hosp.
  • St James’s University Hosp., Leeds
  • University College London Hosp.

More detail

Direct selection techniques are used whereby CMV-specific T cells are isolated from a CMV seropositive sibling donor sample and infused into a CMV seropositive recipient, in order to prevent CMV infection during the immuno-compromised period post transplant.

Eligible patients are pre-conditioned with Campath as part of their allo-HSCT procedure. The primary endpoints of the study investigate the number of patients experiencing a recurrent episode of CMV reactivation after primary reactivation.

Patients recruited to the study undergo transplant and are followed up according to standard practice. The original stem cell sibling donor then attends for a second study-dedicated specific apheresis, from which CMV-specific T cell selection is carried out to produce the CMV product, Cytovir CMV. Cytovir CMV is administered on a prophylactic basis at day 27 post transplant, after which patients are followed up according to standard practice.

The primary objective for the study is the number of patients experiencing a recurrent episode of CMV reactivation after primary reactivation.

Further endpoints include: incidence and severity of GVHD; duration of antiviral drug therapy (total days) and of viraemia (total days); incidence of CMV disease; laboratory evidence of reconstitution and persistence of CMV-specific immunity.