Thymosin Alpha-1 for irAE Secondary to ICIs

Summary

Thymosin alpha-1 (Tα-1) has shown clinical benefits in patients whose immune functions are severely compromised or ineffective. Therefore, this study is attempted to explore whether Tα-1 could be used as a therapeutic option for the treatment of immune-related adverse events (irAEs).

Timeline

Start

2023-09-01

Primary completion

2024-11

Completion

2025-04

Publications

• Results Serafino A, Pierimarchi P, Pica F, Andreola F, Gaziano R, Moroni N, Zonfrillo M, Sinibaldi-Vallebona P, Garaci E. Thymosin alpha1 as a stimulatory agent of innate cell-mediated immune response. Ann N Y Acad Sci. 2012 Oct;1270:13-20. doi: 10.1111/j.1749-6632.2012.06707.x.
• Results Romani L, Oikonomou V, Moretti S, Iannitti RG, D'Adamo MC, Villella VR, Pariano M, Sforna L, Borghi M, Bellet MM, Fallarino F, Pallotta MT, Servillo G, Ferrari E, Puccetti P, Kroemer G, Pessia M, Maiuri L, Goldstein AL, Garaci E. Thymosin alpha1 represents a potential potent single-molecule-based therapy for cystic fibrosis. Nat Med. 2017 May;23(5):590-600. doi: 10.1038/nm.4305. Epub 2017 Apr 10.
• Results Renga G, Bellet MM, Pariano M, Gargaro M, Stincardini C, D'Onofrio F, Mosci P, Brancorsini S, Bartoli A, Goldstein AL, Garaci E, Romani L, Costantini C. Thymosin alpha1 protects from CTLA-4 intestinal immunopathology. Life Sci Alliance. 2020 Aug 14;3(10):e202000662. doi: 10.26508/lsa.202000662. Print 2020 Oct.
• Results Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
• Results Liu J, Shen Y, Wen Z, Xu Q, Wu Z, Feng H, Li Z, Dong X, Huang S, Guo J, Zhang L, Chen Y, Li W, Zhu W, Du H, Liu Y, Wang T, Chen L, Teboul JL, Annane D, Chen D. Efficacy of Thymosin Alpha 1 in the Treatment of COVID-19: A Multicenter Cohort Study. Front Immunol. 2021 Aug 2;12:673693. doi: 10.3389/fimmu.2021.673693. eCollection 2021.
• Results Liu F, Qiu B, Xi Y, Luo Y, Luo Q, Wu Y, Chen N, Zhou R, Guo J, Wu Q, Xiong M, Liu H. Efficacy of Thymosin alpha1 in Management of Radiation Pneumonitis in Patients With Locally Advanced Non-Small Cell Lung Cancer Treated With Concurrent Chemoradiotherapy: A Phase 2 Clinical Trial (GASTO-1043). Int J Radiat Oncol Biol Phys. 2022 Nov 1;114(3):433-443. doi: 10.1016/j.ijrobp.2022.07.009. Epub 2022 Jul 21.

Drugs

Indications

No indication recorded.