biostudies-literatureUnknown68(5)Sebastian MCureVac AGCV9201 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 injecCancer immunology, immunotherapy : CII799-812https://www.ebi.ac.uk/biostudies/studies/S-EPMC11028316biostudies-literatureA phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer.PMC11028316Fotin-Mleczek MReck MMayer FSebastian Mvon Boehmer LKallen KJMuth AThomas MBernhard HLander TGnad-Vogt USchneller FHong HSGroschel AHoerr IKnuth AKoch SDProbst Jvon der Muelbe FZippelius AStrack TStohlmacher JScheel BWiegand VSchroder AAtanackovic DfalseA 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) 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 injec2019-01-01T00:00:00Z2019 May2025-04-22T20:46:28.12Z2025-04-06T03:16:22.978ZS-EPMC110283163077095910.1007/s00262-019-02315-x