Site feasibility assessment and final site selection and contracts are needed for approximately 20-25 sites (3rd party as subcontractors). LMU will coordinate the site selection and will set up a contact office for all clinical and regulatory questions raised by physicians that treat patients or may have candidates for an inclusion into this clinical trial. LMU, OPBG, LUMC, CHU, UNEW and UZG will select the clinical sites for recruitment of patients in their Country.
Therefore, the functional activity of T cells specific for immunodominant epitopes derived from different proteins of the targeted viruses (e.g. CMV, EBV, and AdV) presented by different HLA alleles will be determined. On target (anti-viral) reactivity of the isolated T-cell products will be analysed upon stimulation with peptides/peptide pools of the different viral antigens, and functional reactivity will be assessed by flow cytometry using counterstaining with CD4/8 antibodies and staining for specific activation markers (CD137, CD154) and relevant cytokines (IFNγ, IL-4, GM-CSF).
A second approval package will contain all approvals from ethics committees and national competent authorities from more than 12 study sites once the last approval has been received.
The clinical trial documents will be submitted to the competent authorities and the ethical review boards. The partners LMU, OPBG, LUMC, CHU, UNEW, UZG are involved in this task. The task leader LMU will submit the trial to the German competent authority Paul-Ehrlich-Institut. The role of all other participants (OPBG, LUMC, CHU, UNEW, UZG) will be to submit the trial to their national and local authorities.
Patient organisations will be included in a three level approach. Patient organisations will be involved in dissemination (local level), a representative of the national umbrella organisation will be part of the advisory board (national level) and the consortium will be represented at the “Patient and Family Day” of the EBMT (European Group for Blood and Marrow Transplantation).
The clinical trial documents will be submitted to the competent authorities and the ethical review boards. The partners LMU, OPBG, LUMC, CHU, UNEW, UZG are involved in this task. The task leader LMU will submit the trial to the German competent authority Paul-Ehrlich-Institut. The role of all other participants (OPBG, LUMC, CHU, UNEW, UZG) will be to submit the trial to their national and local authorities. Deliverables D 2.5 and 2.6 are the outcome of this task, which will contain the whole submission package, including the final version of the study protocol as approved by competent authorities.
immune monitoring of peripheral blood and bone marrow samples taken from the patients enrolled in the clinical trial described in this proposal are of utmost importance. Blood samples and if possible bone marrow samples will be drawn from the patients before the infusion of the multivirus- specific T-cell product and at different time-points afterwards. The presence of T cells directed against the targeted viruses (e.g. CMV, EBV and AdV) will be analysed by multi-colour flow cytometry using HLA/peptide multimers for known immunodominant viral epitopes combined with antibodies for different T-cell phenotypes (central memory, effector memory, memory stem T cells or effector T cells). Also restimulation experiments with viral peptide pools, followed by counterstaining with CD4/8 antibodies and staining for specific activation markers (CD137, CD154) and/or relevant cytokines (IFNγ, IL-4, GM-CSF) will be used.
LMU will set up and perform maintenance of the consortium homepage and social media accounts such as LinkedIn, Facebook or Twitter dependent on the preference of patient organisations. All participants of the consortium will provide information for the website.
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Author(s): Theresa Kaeuferle, Ramona Krauss, Franziska Blaeschke, Semjon Willier, Tobias Feuchtinger
Published in: Journal of Hematology & Oncology, 12/1, 2019, Page(s) 12-13, ISSN 1756-8722
Publisher: BioMed Central