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® (CCS)
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).
Cytokine Capture System®
Biological: IFN-γ positive selected T-cells
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Single-center 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®|
- Level of enriched IFN-γ+ T-cells [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Treatment efficacy [ Time Frame: 7 days ] [ Designated as safety issue: No ]Treatment efficacy defined as reduction of virus load, in vivo expansion of antigen-specific T cells in peripheral blood as well as reduction of clinical signs of specific viral infection
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: allogeneic HSCT
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 SOT recipients.
|Biological: IFN-γ positive selected T-cells|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02007356
|Contact: Nina Khanna, MD||+41-61-2652525 (Zentrale)||email@example.com|
|Basel, Switzerland, 4031|
|Contact: Nina Khanna, Dr. 0041-61- ext 7325 firstname.lastname@example.org|
|Principal Investigator: Nina Khanna, Dr.|
|Principal Investigator:||Nina Khanna, Dr.||Universitätsspital Basel,Klinik für Infektiologie und Spitalhygiene, Petersgraben 4, Switzerland 4031|