Phase I Study of Safety and Tolerability of Intratumoral Macrophage-Derived Exosomes with Mechanobiological Reprogramming in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are studying adults aged 18 to 65 years with advanced solid tumors who have not responded to, cannot receive, or do not tolerate standard treatments. This phase I trial aims to evaluate the safety and tolerability of intratumoral injections of mechanobiologically reprogrammed macrophage-derived exosomes. The study is open-label and non-randomized, focusing on dose escalation to find a safe dose level. Participants receive injections of these specially prepared exosomes directly into their tumors every two weeks for four doses. Three dose levels are being tested 1 x 1010, 2.5 x 1010, and 5 x 1010 exosomes per injection. These exosomes are made from the participants own blood cells, reprogrammed through a special process, and purified before injection. The study follows a 33 dose escalation design. During the trial, participants will be monitored closely for dose-limiting toxicities for about four weeks after the first dose. Researchers will also assess tumor response, progression-free survival, overall survival, and treatment-related side effects over several months up to two years. The total duration of participation depends on individual outcomes and follow-up schedules, with safety assessments continuing for six months post-treatment.

Intratumoral Macrophage Exosomes With Mechanobiological Reprogramming for Advanced Solid Tumors