RTX001 Autologous Engineered Macrophages for Liver Cirrhosis

Summary

The purpose of this study is to assess the safety and efficacy of RTX001 in patients with end-stage liver disease. This study is the first time RTX001, a macrophage cell therapy engineered to have an anti-inflammatory and anti-fibrotic effect, will be given to humans.

Timeline

Start

2024-10-15

Primary completion

2028-08-29

Completion

2028-11-29

Publications

• Background Forbes S et al., Hepatology. AASLD Abstract #0095 (2024)
• Background Brennan et al., Hepatology. AASLD Abstract #160 (2023) https://www.aasld.org/the-liver-meeting/open-label-parallel-group-phase-ii-randomised-controlled-trial-autologous
• Background LBP-007 Beneficial effects of autologous macrophage therapy on clinical outcomes in patients with compensated cirrhosis: extended follow-up data from a randomized controlled phase 2 trial Brennan, Paul et al. Journal of Hepatology, Volume 80, S81 DOI: 10.1016/S0168-8278(24)00574-9
• Background Moroni F, Dwyer BJ, Graham C, Pass C, Bailey L, Ritchie L, Mitchell D, Glover A, Laurie A, Doig S, Hargreaves E, Fraser AR, Turner ML, Campbell JDM, McGowan NWA, Barry J, Moore JK, Hayes PC, Leeming DJ, Nielsen MJ, Musa K, Fallowfield JA, Forbes SJ. Safety profile of autologous macrophage therapy for liver cirrhosis. Nat Med. 2019 Oct;25(10):1560-1565. doi: 10.1038/s41591-019-0599-8. Epub 2019 Oct 7.

Drugs

Indications