Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections
Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with r
| Condition(s) | AdV Infection, EBV Infection, CMV Infection, Stem Cell Transplant Complications |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults. |
| Who can participate | Inclusion Criteria: 1. Adult or paediatric patients (\> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection refractory to standard antiviral treatment for two weeks (defined as no decrease or insignificant decrease of less than 1log in viral load over two weeks) as confirmed by quantitative blood PCR analysis. 2. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection. 3. Written informed consent given (patient or legal representative) prior to any study-related procedures. Exclusion Criteria: 1. Patient with acute GvHD \> grade II or extensive chronic GvHD at the time of IMP transfer 2. Patient receiving steroid |
| Ages | 2 Months |
| Sex | All |
| Lead sponsor | Tobias Feuchtinger |
| Locations | Brussels, Belgium; Brussels, Belgium; Ghent, Belgium; Leuven, Belgium; Liège, Belgium; Lille, France (+27 more sites) |
| Start date | 2019-08-27 |
| NCT ID | NCT04832607 |
| Official listing | https://clinicaltrials.gov/study/NCT04832607 |