Open-label Phase 12 Study Evaluating the Safety and Effectiveness of YTB323 in Adults with Relapsing Multiple Sclerosis Experiencing Breakthrough Disease Activity During Previous Highly Effective Treatment

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and behavior of the investigational drug YTB323 in about 28 adults aged 18 to 60 with relapsing multiple sclerosis RMS who have shown disease activity despite previous treatment with highly effective therapies. This is an open-label, multi-center, phase 12 study using a dose-escalation design with sentinel groups followed by a larger expansion group to assess different dose levels of YTB323. All participants will receive a single dose of YTB323, a CAR-T cell therapy given by intravenous infusion. Different participant groups may receive higher doses if lower doses are safe. Participants will be involved in the study for 2 years of active follow-up and will then continue to be monitored for an additional 13 years in a long-term follow-up phase. During the study, participants will undergo various assessments including monitoring for adverse events and serious adverse events, disability evaluations using multiple tests like the Expanded Disability Status Scale and Timed 25 Foot Walk, MRI scans to track brain lesions, and blood tests to measure how the drug behaves in the body. Safety data and immune responses will also be closely observed throughout the 2-year treatment period, with long-term monitoring continuing afterward.

An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis