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TRACE SIGNED

Transfer of multivirus-specific T-cells following transplantation

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

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.

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

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 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.	DE (MUENCHEN)	coordinator	1˙641˙600.00
2	ORION CLINICAL SERVICES LTD ORION CLINICAL SERVICES LTD Organization address address: BATH ROAD 7 city: SLOUGH postcode: SL13UA website: www.orioncro.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (SLOUGH)	participant	2˙099˙005.00
3	CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE NANCY CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE NANCY Organization address address: AVENUE MAR DE LATTRE TASSIGNY 29 city: NANCY CEDEX postcode: 54035 website: www.chu-nancy.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (NANCY CEDEX)	participant	507˙570.00
4	OSPEDALE PEDIATRICO BAMBINO GESU OSPEDALE PEDIATRICO BAMBINO GESU Organization address address: PIAZZA SANT ONOFRIO 4 city: ROMA postcode: 165 website: www.ospedalebambinogesu.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROMA)	participant	442˙025.00
5	Universitair Ziekenhuis Gent Universitair Ziekenhuis Gent Organization address address: De Pintelaan 185 city: Gent postcode: 9000 website: http://www.uzgent.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (Gent)	participant	401˙550.00
6	ACADEMISCH ZIEKENHUIS LEIDEN ACADEMISCH ZIEKENHUIS LEIDEN Organization address address: ALBINUSDREEF 2 city: LEIDEN postcode: 2333 ZA website: www.lumc.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (LEIDEN)	participant	350˙600.00
7	UNIVERSITY OF NEWCASTLE UPON TYNE UNIVERSITY OF NEWCASTLE UPON TYNE Organization address address: KINGS GATE city: NEWCASTLE UPON TYNE postcode: NE1 7RU website: http://www.ncl.ac.uk/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (NEWCASTLE UPON TYNE)	participant	349˙725.00
8	MILTENYI BIOTEC GMBH MILTENYI BIOTEC GMBH Organization address address: FRIEDRICH EBERT STRASSE 68 city: BERGISH GLADBACH postcode: 51429 website: www.miltenyibiotec.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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

List of publications.
year	authors and title	journal	last update
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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