ASPIRE - Adenovirus Specific Paediatric Immune Reconstitution

• Research type

  Research Study

• Full title

  A Phase I/II clinical trial to investigate the safety of adenovirus-specific T-cells given to high-risk paediatric patients post allogeneic haematopoietic stem cell transplant (HSCT) to treat reactivation of adenovirus.

• IRAS ID

  94361

• Contact name

  Waseem Qasim

• Sponsor organisation

  Cell Medica Ltd.

• Eudract number

  2011-001788-36

• ISRCTN Number

  ISRCTN22322271

• Research summary

  Adenovirus (ADV) infections account for 10% acute respiratory infections in children but are unlikely to cause serious complications in healthy patients. Following bone marrow transplant, ADV infection occurs in approximately 30% of paediatric patients and may be responsible for as many as 10% of post-transplant paediatric deaths. Antiviral drugs have some success, but no drug available is indicated for this patient group; current treatment options do not restore immune function. Additionally, non-specific toxicities that are associated with currently available antiviral drugs may increase the levels of morbidity in these patients. ADV T cells, derived from peripheral blood mononuclear cells, can be rapidly expanded when exposed to ADV antigen over a 10 day period. The expanded cell population is harvested, washed, counted and frozen in specific cell dosages which are administered to patients following evidence of ADV infection (positive PCR results). The participants will be patients considered at highest risk of infection; paediatric patients with unrelated donors, mismatched family donors or haploidentical donors. Following transplant, the patients are routinely monitored for ADV viraemia and following two consecutive PCR positive results, the selected cell dose will be infused. If a patient is still exhibiting uncontrolled ADV viraemia four weeks following the cell infusion, they will be infused with a higher cell dose. Throughout the study the patients will be asked to give blood samples that will be assessed for levels of ADV-specific immune reconstitution and competent immune function. The study is a first-in-man safety study to evaluate if the infusion of adoptive ADV specific T cells will lead to toxicities or increase the incidence of Graft Versus Host Disease (GVHD). Throughout the study patients will be closely monitored for symptoms of GVHD and additional toxicities through routine medical assessments. Evidence of efficacy demonstrated by clearance of adenoviraemia will also be recorded.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/1008

• Date of REC Opinion

  23 Aug 2012

• REC opinion

  Further Information Favourable Opinion