A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

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The trial is looking for adults who had a stem cell transplant from a donor (allogeneic HSCT). They must have an adenovirus, CMV or EBV infection that did not get better with treatment.

Életkor

Adults over 18 years, up to 65 years.

Nem

All sexes can join.

A betegség stádiuma

Viral infection after transplant with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) that has not responded to treatment.

Korábbi kezelés

Adenovirus: cidofovir for at least 7 days without response, or antiviral treatment not allowed. EBV: at least one anti-CD20 antibody treatment (375 mg/m2) without response or with worsening. CMV: ganciclovir or foscavir for 14 days without response, or more than 2 returns of the infection despite it, or antiviral treatment not allowed.

Biomarker vagy leletérték

Virus load did not drop by more than 1 log, or rose, on treatment; or CD3+ cells below 300/µL.

A részvétel fő kizáró okai

• Graft-versus-host disease worse than grade 2 at the planned infusion time
• Known allergy to iron-dextran
• Known allergy to murine (mouse) antibodies

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 18 és 65 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment refractory post-transplant viral infections. The CCS has already been successfully used in clinical studies in Germany and United Kingdom (UK).

A vizsgálat csoportja

• allogeneic HSCTA vizsgált kezelés

  The present study will evaluate and validate in a single-center, open-label, single arm fashion the safety and feasibility of direct infusions of donor-derived pathogen-specific IFN-γ positive T-cells in recipients of HSCT with post-transplant viral infection according to the previously clinically certified CCS® \[3-6\]. The Investigator will first generate and apply IFN-γ positive selected T-cells to recipients of HSCT with CMV, EBV or adenovirus as previously published. The Investigator aim is to include 6 patients from the University Hospital of Basel. With confirmed safety the investigator will in the future perform an efficacy study and extend this treat-ment for other clinically relevant pathogens including human herpesvirus (HHV)-6, HHV-8, polyomaviruses JC and BK and fungi including Aspergillus fumigatus and Candida albicans, to other immunosuppressed patients such as solid organ transplant (SOT) recipients.

  Kezelés: IFN-γ positive selected T-cells