Universität zu Köln

von Einem, Jobst Christian, Guenther, Christine, Volk, Hans-Dieter ORCID: 0000-0002-7743-6668, Gruetz, Gerald, Hirsch, Daniela, Salat, Christoph, Stoetzer, Oliver, Nelson, Peter J., Michl, Marlies, Modest, Dominik P., Holch, Julian W., Angele, Martin, Bruns, Christiane, Niess, Hanno and Heinemann, Volker (2019). Treatment of advanced gastrointestinal cancer with genetically modified autologous mesenchymal stem cells: Results from the phase 1/2 TREAT-ME-1 trial. Int. J. Cancer, 145 (6). S. 1538 - 1547. HOBOKEN: WILEY. ISSN 1097-0215

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Abstract

TREAT-ME-1, a Phase 1/2 open-label multicenter, first-in-human, first-in-class trial, evaluated the safety, tolerability and efficacy of treatment with genetically modified autologous mesenchymal stromal cells (MSC), MSC_ apceth_101, in combination with ganciclovir in patients with advanced gastrointestinal adenocarcinoma. Immunological and inflammatory markers were also assessed. All patients (3 in Phase 1; 7 in Phase 2) received three treatment cycles of MSC_apceth_101 at one dose level on Day 0, 7, and 14 followed by ganciclovir administration according to the manufacturer's instructions for 4872 h after MSC_apceth_101 injection. Ten patients were treated with a total dose of 3.0 x 10(6) cells/kg MSC_apceth_101. 36 adverse events and six serious adverse events were reported. Five patients achieved stable disease (change in target lesions of -2 to +28%). For all patients, the median time to progression was 1.8 months (95% CI: 0.5, 3.9 months). Median overall survival could not be estimated as 8/10 patients were still alive at the end of the study (1 year) and therefore censored. Post-study observation of patients showed a median overall survival of 15.6 months (ranging from 2.227.0 months). Treatment with MSC_apceth_101 and ganciclovir did not induce a consistent increase or decrease in levels of any of the tumor markers analyzed. No clear trends in the immunological markers assessed were observed. MSC_apceth_101 in combination with ganciclovir was safe and tolerable in patients with advanced gastrointestinal adenocarcinoma, with preliminary signs of efficacy in terms of clinical stabilization of disease.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code von Einem, Jobst Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Guenther, Christine UNSPECIFIED UNSPECIFIED UNSPECIFIED Volk, Hans-Dieter UNSPECIFIED orcid.org/0000-0002-7743-6668 UNSPECIFIED Gruetz, Gerald UNSPECIFIED UNSPECIFIED UNSPECIFIED Hirsch, Daniela UNSPECIFIED UNSPECIFIED UNSPECIFIED Salat, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Stoetzer, Oliver UNSPECIFIED UNSPECIFIED UNSPECIFIED Nelson, Peter J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Michl, Marlies UNSPECIFIED UNSPECIFIED UNSPECIFIED Modest, Dominik P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Holch, Julian W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Angele, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Bruns, Christiane UNSPECIFIED UNSPECIFIED UNSPECIFIED Niess, Hanno UNSPECIFIED UNSPECIFIED UNSPECIFIED Heinemann, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-141361
DOI:	10.1002/ijc.32230
Journal or Publication Title:	Int. J. Cancer
Volume:	145
Number:	6
Page Range:	S. 1538 - 1547
Date:	2019
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1097-0215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TUMOR-ASSOCIATED MACROPHAGES; CHOLANGIOCARCINOMA; NOMENCLATURE; POLARIZATION; EXPRESSION; DELIVERY; GROWTH Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/14136