Study of TRX319 Cell Therapy Safety and Effectiveness for Adults Aged 18 to 65 with Primary or Secondary Progressive Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the safety and best dose of TRX319, a cell therapy, in adults with two types of progressive Multiple Sclerosis MS primary progressive and secondary progressive MS. The study also investigates whether pre-conditioning with Bendamustine improves TRX319s ability to treat these forms of MS. This open-label Phase 12a trial aims to understand how TRX319 works and its safety profile in these patients. Participants may receive up to three doses of TRX319 over the course of one year. Some receive pre-conditioning with Bendamustine before TRX319 infusion to see if it enhances treatment effects. The study includes six groups with different dose levels, some with and some without pre-conditioning. Researchers will monitor participants closely throughout the treatment period. During the study, participants will undergo blood tests, MRI scans, and lumbar punctures to track safety and treatment impact on MS. Researchers will assess disease progression and immune markers for up to 12 months after treatment. Participants will be followed and evaluated regularly to measure outcomes such as disability status and changes in brain inflammation.

Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis