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:
CreatorsEmailORCIDORCID Put Code
von Einem, Jobst ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Guenther, ChristineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Volk, Hans-DieterUNSPECIFIEDorcid.org/0000-0002-7743-6668UNSPECIFIED
Gruetz, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hirsch, DanielaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salat, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stoetzer, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nelson, Peter J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Michl, MarliesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Modest, Dominik P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Holch, Julian W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Angele, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bruns, ChristianeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Niess, HannoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinemann, VolkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
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:
KeywordsLanguage
TUMOR-ASSOCIATED MACROPHAGES; CHOLANGIOCARCINOMA; NOMENCLATURE; POLARIZATION; EXPRESSION; DELIVERY; GROWTHMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/14136

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