A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer

CV9201 is an RNActive®-based cancer immunotherapy encoding five non-small cell lung cancer-antigens: New York esophageal squamous cell carcinoma-1, melanoma antigen family C1/C2, survivin, and trophoblast glycoprotein. In a phase I/IIa dose-escalation trial, 46 patients with locally advanced (n = 7)...

Full description

Saved in:
Bibliographic Details
Main Authors: Sebastian, Martin (Author) , Thomas, Michael (Author)
Format: Article (Journal)
Language:English
Published: 15 February 2019
In: Cancer immunology immunotherapy
Year: 2019, Volume: 68, Issue: 5, Pages: 799-812
ISSN:1432-0851
DOI:10.1007/s00262-019-02315-x
Online Access:Verlag, Pay-per-use, Volltext: https://doi.org/10.1007/s00262-019-02315-x
Get full text
Author Notes:Martin Sebastian, Andreas Schröder, Birgit Scheel, Henoch S. Hong, Anke Muth, Lotta von Boehmer, Alfred Zippelius, Frank Mayer, Martin Reck, Djordje Atanackovic, Michael Thomas, Folker Schneller, Jan Stöhlmacher, Helga Bernhard, Andreas Gröschel, Thomas Lander, Jochen Probst, Tanja Strack, Volker Wiegand, Ulrike Gnad-Vogt, Karl-Josef Kallen, Ingmar Hoerr, Florian von der Muelbe, Mariola Fotin-Mleczek, Alexander Knuth, Sven D. Koch

MARC

LEADER 00000caa a2200000 c 4500
001 1678233129
003 DE-627
005 20230427193429.0
007 cr uuu---uuuuu
008 191007s2019 xx |||||o 00| ||eng c
024 7 |a 10.1007/s00262-019-02315-x  |2 doi 
035 |a (DE-627)1678233129 
035 |a (DE-599)KXP1678233129 
035 |a (OCoLC)1341244883 
040 |a DE-627  |b ger  |c DE-627  |e rda 
041 |a eng 
084 |a 33  |2 sdnb 
100 1 |a Sebastian, Martin  |d 1965-  |e VerfasserIn  |0 (DE-588)129885916  |0 (DE-627)482779640  |0 (DE-576)297886975  |4 aut 
245 1 2 |a A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer  |c Martin Sebastian, Andreas Schröder, Birgit Scheel, Henoch S. Hong, Anke Muth, Lotta von Boehmer, Alfred Zippelius, Frank Mayer, Martin Reck, Djordje Atanackovic, Michael Thomas, Folker Schneller, Jan Stöhlmacher, Helga Bernhard, Andreas Gröschel, Thomas Lander, Jochen Probst, Tanja Strack, Volker Wiegand, Ulrike Gnad-Vogt, Karl-Josef Kallen, Ingmar Hoerr, Florian von der Muelbe, Mariola Fotin-Mleczek, Alexander Knuth, Sven D. Koch 
264 1 |c 15 February 2019 
300 |a 14 
336 |a Text  |b txt  |2 rdacontent 
337 |a Computermedien  |b c  |2 rdamedia 
338 |a Online-Ressource  |b cr  |2 rdacarrier 
500 |a Gesehen am 07.10.2019 
520 |a CV9201 is an RNActive®-based cancer immunotherapy encoding five non-small cell lung cancer-antigens: New York esophageal squamous cell carcinoma-1, melanoma antigen family C1/C2, survivin, and trophoblast glycoprotein. In a phase I/IIa dose-escalation trial, 46 patients with locally advanced (n = 7) or metastatic (n = 39) NSCLC and at least stable disease after first-line treatment received five intradermal CV9201 injections (400-1600 µg of mRNA). The primary objective of the trial was to assess safety. Secondary objectives included assessment of antibody and ex vivo T cell responses against the five antigens, and changes in immune cell populations. All CV9201 dose levels were well-tolerated and the recommended dose for phase IIa was 1600 µg. Most AEs were mild-to-moderate injection site reactions and flu-like symptoms. Three (7%) patients had grade 3 related AEs. No related grade 4/5 or related serious AEs occurred. In phase IIa, antigen-specific immune responses against ≥ 1 antigen were detected in 63% of evaluable patients after treatment. The frequency of activated IgD+CD38hi B cells increased > twofold in 18/30 (60%) evaluable patients. 9/29 (31%) evaluable patients in phase IIa had stable disease and 20/29 (69%) had progressive disease. Median progression-free and overall survival were 5.0 months (95% CI 1.8-6.3) and 10.8 months (8.1-16.7) from first administration, respectively. Two- and 3-year survival rates were 26.7% and 20.7%, respectively. CV9201 was well-tolerated and immune responses could be detected after treatment supporting further clinical investigation. 
650 4 |a Active cancer immunotherapy 
650 4 |a Clinical trial 
650 4 |a CV9201 
650 4 |a Immunomonitoring 
650 4 |a mRNA 
650 4 |a Non-small cell lung cancer 
700 1 |a Thomas, Michael  |e VerfasserIn  |0 (DE-588)1054438781  |0 (DE-627)79152213X  |0 (DE-576)41027089X  |4 aut 
773 0 8 |i Enthalten in  |t Cancer immunology immunotherapy  |d Berlin : Springer, 1976  |g 68(2019), 5, Seite 799-812  |h Online-Ressource  |w (DE-627)253390443  |w (DE-600)1458489-X  |w (DE-576)072283475  |x 1432-0851  |7 nnas  |a A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer 
773 1 8 |g volume:68  |g year:2019  |g number:5  |g pages:799-812  |g extent:14  |a A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer 
856 4 0 |u https://doi.org/10.1007/s00262-019-02315-x  |x Verlag  |x Resolving-System  |z Pay-per-use  |3 Volltext 
951 |a AR 
992 |a 20191007 
993 |a Article 
994 |a 2019 
998 |g 1054438781  |a Thomas, Michael  |m 1054438781:Thomas, Michael  |d 910000  |d 950000  |d 950900  |e 910000PT1054438781  |e 950000PT1054438781  |e 950900PT1054438781  |k 0/910000/  |k 1/910000/950000/  |k 2/910000/950000/950900/  |p 11 
999 |a KXP-PPN1678233129  |e 3520045907 
BIB |a Y 
SER |a journal 
JSO |a {"title":[{"title_sort":"phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer","title":"A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer"}],"recId":"1678233129","relHost":[{"part":{"extent":"14","volume":"68","pages":"799-812","year":"2019","text":"68(2019), 5, Seite 799-812","issue":"5"},"note":["Gesehen am 15.05.2024","Fortsetzung der Druck-Ausgabe","Ungezählte Beil. ab 52.2003: Supplement"],"titleAlt":[{"title":"CII"}],"recId":"253390443","origin":[{"publisherPlace":"Berlin ; Heidelberg","publisher":"Springer","dateIssuedDisp":"1976-","dateIssuedKey":"1976"}],"disp":"A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancerCancer immunology immunotherapy","id":{"eki":["253390443"],"issn":["1432-0851"],"zdb":["1458489-X"]},"language":["eng"],"type":{"bibl":"periodical","media":"Online-Ressource"},"title":[{"subtitle":"CII","title_sort":"Cancer immunology immunotherapy","title":"Cancer immunology immunotherapy"}],"pubHistory":["1.1976 -"],"physDesc":[{"extent":"Online-Ressource"}]}],"origin":[{"dateIssuedKey":"2019","dateIssuedDisp":"15 February 2019"}],"name":{"displayForm":["Martin Sebastian, Andreas Schröder, Birgit Scheel, Henoch S. Hong, Anke Muth, Lotta von Boehmer, Alfred Zippelius, Frank Mayer, Martin Reck, Djordje Atanackovic, Michael Thomas, Folker Schneller, Jan Stöhlmacher, Helga Bernhard, Andreas Gröschel, Thomas Lander, Jochen Probst, Tanja Strack, Volker Wiegand, Ulrike Gnad-Vogt, Karl-Josef Kallen, Ingmar Hoerr, Florian von der Muelbe, Mariola Fotin-Mleczek, Alexander Knuth, Sven D. Koch"]},"physDesc":[{"extent":"14 S."}],"note":["Gesehen am 07.10.2019"],"id":{"doi":["10.1007/s00262-019-02315-x"],"eki":["1678233129"]},"person":[{"given":"Martin","family":"Sebastian","display":"Sebastian, Martin","role":"aut"},{"family":"Thomas","given":"Michael","role":"aut","display":"Thomas, Michael"}],"type":{"bibl":"article-journal","media":"Online-Ressource"},"language":["eng"]} 
SRT |a SEBASTIANMPHASEIIIAS1520