PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.

Summary

Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy

Timeline

Start

2025-10-23

Primary completion

2026-09-30

Completion

2026-12-30

Publications

• Results Chen X, Wu Y, Yang T, Wei M, Wang Y, Deng X, Shen C, Li W, Zhang H, Xu W, Gou L, Zeng Y, Zhang Y, Wang Z, Yang J. Salidroside alleviates cachexia symptoms in mouse models of cancer cachexia via activating mTOR signalling. J Cachexia Sarcopenia Muscle. 2016 May;7(2):225-32. doi: 10.1002/jcsm.12054. Epub 2016 Jan 18.
• Results Wu Y, Li W, Chen X, Wang H, Su S, Xu Y, Deng X, Yang T, Wei M, Li L, Liu Y, Yang J, Li W. DOG1 as a novel antibody-drug conjugate target for the treatment of multiple gastrointestinal tumors and liver metastasis. Front Immunol. 2023 Jan 26;14:1051506. doi: 10.3389/fimmu.2023.1051506. eCollection 2023.
• Results Sabnis S, Kumarasinghe ES, Salerno T, Mihai C, Ketova T, Senn JJ, Lynn A, Bulychev A, McFadyen I, Chan J, Almarsson O, Stanton MG, Benenato KE. A Novel Amino Lipid Series for mRNA Delivery: Improved Endosomal Escape and Sustained Pharmacology and Safety in Non-human Primates. Mol Ther. 2018 Jun 6;26(6):1509-1519. doi: 10.1016/j.ymthe.2018.03.010. Epub 2018 Mar 14.
• Results Selvaggio G, Leonardelli L, Lofano G, Fresnay S, Parolo S, Medini D, Siena E, Marchetti L. A quantitative systems pharmacology approach to support mRNA vaccine development and optimization. CPT Pharmacometrics Syst Pharmacol. 2021 Dec;10(12):1448-1451. doi: 10.1002/psp4.12721. Epub 2021 Oct 21. No abstract available.
• Results Xu S, Yang K, Li R, Zhang L. mRNA Vaccine Era-Mechanisms, Drug Platform and Clinical Prospection. Int J Mol Sci. 2020 Sep 9;21(18):6582. doi: 10.3390/ijms21186582.
• Results Linares-Fernandez S, Lacroix C, Exposito JY, Verrier B. Tailoring mRNA Vaccine to Balance Innate/Adaptive Immune Response. Trends Mol Med. 2020 Mar;26(3):311-323. doi: 10.1016/j.molmed.2019.10.002. Epub 2019 Nov 5.
• Results Verbeke R, Hogan MJ, Lore K, Pardi N. Innate immune mechanisms of mRNA vaccines. Immunity. 2022 Nov 8;55(11):1993-2005. doi: 10.1016/j.immuni.2022.10.014.
• Results Lim SA, Cox A, Tung M, Chung EJ. Clinical progress of nanomedicine-based RNA therapies. Bioact Mater. 2021 Oct 22;12:203-213. doi: 10.1016/j.bioactmat.2021.10.018. eCollection 2022 Jun.
• Results Sebastian M, Schroder A, Scheel B, Hong HS, Muth A, von Boehmer L, Zippelius A, Mayer F, Reck M, Atanackovic D, Thomas M, Schneller F, Stohlmacher J, Bernhard H, Groschel A, Lander T, Probst J, Strack T, Wiegand V, Gnad-Vogt U, Kallen KJ, Hoerr I, von der Muelbe F, Fotin-Mleczek M, Knuth A, Koch SD. A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer. Cancer Immunol Immunother. 2019 May;68(5):799-812. doi: 10.1007/s00262-019-02315-x. Epub 2019 Feb 15.
• Results Hong HS, Koch SD, Scheel B, Gnad-Vogt U, Schroder A, Kallen KJ, Wiegand V, Backert L, Kohlbacher O, Hoerr I, Fotin-Mleczek M, Billingsley JM. Distinct transcriptional changes in non-small cell lung cancer patients associated with multi-antigenic RNActive(R) CV9201 immunotherapy. Oncoimmunology. 2016 Nov 18;5(12):e1249560. doi: 10.1080/2162402X.2016.1249560. eCollection 2016.
• Results Lorentzen CL, Haanen JB, Met O, Svane IM. Clinical advances and ongoing trials on mRNA vaccines for cancer treatment. Lancet Oncol. 2022 Oct;23(10):e450-e458. doi: 10.1016/S1470-2045(22)00372-2.
• Results Yuan Y, Gao F, Chang Y, Zhao Q, He X. Advances of mRNA vaccine in tumor: a maze of opportunities and challenges. Biomark Res. 2023 Jan 18;11(1):6. doi: 10.1186/s40364-023-00449-w.
• Results Miao L, Zhang Y, Huang L. mRNA vaccine for cancer immunotherapy. Mol Cancer. 2021 Feb 25;20(1):41. doi: 10.1186/s12943-021-01335-5.

Drugs

Indications