Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors

Summary

The goal of this phase I clinical trial is to evaluate the safety and tolerability of intratumoral injection of mechanically reprogrammed macrophage-derived exosomes (MRMEs) in adults aged 18-65 years with advanced solid tumors who have failed, are ineligible for, or are intolerant of standard therapies.

Timeline

Start

2026-05-10

Primary completion

2027-03

Completion

2028-05

Publications

• Background Raillard M, Love EJ, Murison PJ. Effect of predosing versus slow administration of propofol on the dose required for anaesthetic induction and on physiologic variables in healthy dogs. Vet Anaesth Analg. 2018 Jul;45(4):414-422. doi: 10.1016/j.vaa.2018.02.004. Epub 2018 Mar 6.
• Background Alatrash N, Narh ES, Yadav A, Kim MJ, Janaratne T, Gabriel J, MacDonnell FM. Synthesis, DNA Cleavage Activity, Cytotoxicity, Acetylcholinesterase Inhibition, and Acute Murine Toxicity of Redox-Active Ruthenium(II) Polypyridyl Complexes. ChemMedChem. 2017 Jul 6;12(13):1055-1069. doi: 10.1002/cmdc.201700240. Epub 2017 Jun 12.
• Background Okoye IS, Coomes SM, Pelly VS, Czieso S, Papayannopoulos V, Tolmachova T, Seabra MC, Wilson MS. MicroRNA-containing T-regulatory-cell-derived exosomes suppress pathogenic T helper 1 cells. Immunity. 2014 Jul 17;41(1):89-103. doi: 10.1016/j.immuni.2014.05.019.
• Background Niu J, Liu Y. The Construction of English Smart Classroom Teaching Mode Based on Deep Learning. Comput Intell Neurosci. 2022 Aug 22;2022:9037010. doi: 10.1155/2022/9037010. eCollection 2022.
• Background Piccolo S, Panciera T, Contessotto P, Cordenonsi M. YAP/TAZ as master regulators in cancer: modulation, function and therapeutic approaches. Nat Cancer. 2023 Jan;4(1):9-26. doi: 10.1038/s43018-022-00473-z. Epub 2022 Dec 23.
• Background Wang H, Guo S, Kim SJ, Shao F, Ho JWK, Wong KU, Miao Z, Hao D, Zhao M, Xu J, Zeng J, Wong KH, Di L, Wong AH, Xu X, Deng CX. Cisplatin prevents breast cancer metastasis through blocking early EMT and retards cancer growth together with paclitaxel. Theranostics. 2021 Jan 1;11(5):2442-2459. doi: 10.7150/thno.46460. eCollection 2021.
• Background Reiss KA, Angelos MG, Dees EC, Yuan Y, Ueno NT, Pohlmann PR, Johnson ML, Chao J, Shestova O, Serody JS, Schmierer M, Kremp M, Ball M, Qureshi R, Schott BH, Sonawane P, DeLong SC, Christiano M, Swaby RF, Abramson S, Locke K, Barton D, Kennedy E, Gill S, Cushing D, Klichinsky M, Condamine T, Abdou Y. CAR-macrophage therapy for HER2-overexpressing advanced solid tumors: a phase 1 trial. Nat Med. 2025 Apr;31(4):1171-1182. doi: 10.1038/s41591-025-03495-z. Epub 2025 Feb 7.
• Background Song Y, Soto J, Chen B, Yang L, Li S. Cell engineering: Biophysical regulation of the nucleus. Biomaterials. 2020 Mar;234:119743. doi: 10.1016/j.biomaterials.2019.119743. Epub 2020 Jan 3.
• Background Kalukula Y, Stephens AD, Lammerding J, Gabriele S. Mechanics and functional consequences of nuclear deformations. Nat Rev Mol Cell Biol. 2022 Sep;23(9):583-602. doi: 10.1038/s41580-022-00480-z. Epub 2022 May 5.
• Background Song Y, Soto J, Chen B, Hoffman T, Zhao W, Zhu N, Peng Q, Liu L, Ly C, Wong PK, Wang Y, Rowat AC, Kurdistani SK, Li S. Transient nuclear deformation primes epigenetic state and promotes cell reprogramming. Nat Mater. 2022 Oct;21(10):1191-1199. doi: 10.1038/s41563-022-01312-3. Epub 2022 Aug 4.

Drugs

Indications