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TRACE SIGNED

Transfer of multivirus-specific T-cells following transplantation

Total Cost €

0

EC-Contrib. €

0

Partnership

0

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 TRACE project word cloud

Explore the words cloud of the TRACE project. It provides you a very rough idea of what is the project "TRACE" about.

individualized    limited    transfer    adv    refractory    procedure    hsct    receiving    cell    facilities    safety    viral    adenovirus    health    body    safe    standard    deficient    cmv    barr    saving    milestone    curative    infection    life    survival    cellular    unsolved    diseases    basic    trials    lack    overcome    ebv    prospective    standardized    compromized    treatment    self    immune    hurdles    agents    virus    excellence    transplantation    protective    thereby    prove    time    individuals    national    daily    breakthrough    epstein    gmp    structural    variety    expertise    immunity    regulatory    patients    economics    infections    restored    physiological    quality    options    manufacturing    first    none    intensive    efficacy    stem    protection    industrial    allogeneic    proven    cytomegalovirus    qualification    instead    trace    medicine    human    toxic    translation    personalized    adoptive    post    lacking    trial    threatening    routine    immunotherapy    sct    rare    clinical   

Project "TRACE" data sheet

The following table provides information about the project.

Coordinator
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN 

Organization address
address: GESCHWISTER SCHOLL PLATZ 1
city: MUENCHEN
postcode: 80539
website: www.uni-muenchen.de

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Germany [DE]
 Project website http://www.trace-study.de
 Total cost 6˙000˙000 €
 EC max contribution 6˙000˙000 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2017-Two-Stage-RTD
 Funding Scheme RIA
 Starting year 2018
 Duration (year-month-day) from 2018-01-01   to  2022-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN DE (MUENCHEN) coordinator 1˙641˙600.00
2    ORION CLINICAL SERVICES LTD UK (SLOUGH) participant 2˙099˙005.00
3    CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE NANCY FR (NANCY CEDEX) participant 507˙570.00
4    OSPEDALE PEDIATRICO BAMBINO GESU IT (ROMA) participant 442˙025.00
5    Universitair Ziekenhuis Gent BE (Gent) participant 401˙550.00
6    ACADEMISCH ZIEKENHUIS LEIDEN NL (LEIDEN) participant 350˙600.00
7    UNIVERSITY OF NEWCASTLE UPON TYNE UK (NEWCASTLE UPON TYNE) participant 349˙725.00
8    MILTENYI BIOTEC GMBH DE (BERGISH GLADBACH) participant 207˙925.00

Map

 Project objective

Allogeneic stem cell transplantation (HSCT) is a curative treatment for a variety of diseases. Viral infections such as Cytomegalovirus (CMV), Epstein-Barr-virus (EBV) and Adenovirus (AdV) are major unsolved problems for patients receiving allogeneic HSCT. Refractory viral infections post-HSCT are rare, life-threatening conditions due to the deficient T-cell response post-SCT and lacking effective treatment options. Protective T-cell immunity could be restored by means of a procedure known as adoptive T-cell transfer. Although cellular immunotherapy is considered a major recent breakthrough in medicine, none of the cellular treatment approaches has yet become a standard treatment. The reason for this limited translation into daily clinical practice is the lack of controlled, prospective clinical trials investigating efficacy of immunotherapy. The objective of TRACE is to bring adoptive T-cell transfer into clinical routine as a life-saving, curative and safe treatment for refractory viral infection post-HSCT. TRACE is a multi-national clinical trial to prove efficacy and safety of adoptive T-cell transfer in immune-compromized individuals. For the first time, this trial will show that a unique individualized immunotherapy could be included into evidence based clinical routine in rare diseases. Regulatory and structural hurdles will be overcome by standardized GMP-procedures. It will be a major milestone in the development of medicine and health economics to bring such a unique personalized treatment approach into a clinical efficacy trial. The consortium provide excellence in immunotherapy through partners from basic, clinical and industrial research and GMP facilities, with proven qualification and expertise in the field of HSCT, GMP manufacturing and adoptive T-cell transfer. It will bring medicine towards physiological self-protection of the human body instead of cost-intensive toxic agents and will thereby improve survival and quality of life.

 Deliverables

List of deliverables.
Individualized press release for every partner Documents, reports 2020-04-07 22:49:03
Registration number of clinical study in a WHO- or ICMJE-approved registry Documents, reports 2020-04-07 22:49:03
Final version of study protocol as approved by first regulatory/ethics committee (Package 1) Documents, reports 2020-04-07 22:49:03
Launch of website and social media account Websites, patent fillings, videos etc. 2020-04-07 22:49:03
Plan for the analysis of the functional activity of the multivirus-specific T cell product Documents, reports 2020-04-07 22:49:03
SOP for immune monitoring of patient samples Documents, reports 2020-04-07 22:49:03
Site selection Documents, reports 2020-04-07 22:49:03

Take a look to the deliverables list in detail:  detailed list of TRACE deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Theresa Kaeuferle, Ramona Krauss, Franziska Blaeschke, Semjon Willier, Tobias Feuchtinger
Strategies of adoptive T -cell transfer to treat refractory viral infections post allogeneic stem cell transplantation
published pages: 12-13, ISSN: 1756-8722, DOI: 10.1186/s13045-019-0701-1
Journal of Hematology & Oncology 12/1 2020-04-07

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The information about "TRACE" are provided by the European Opendata Portal: CORDIS opendata.

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