drugset / Trial / NCT06617793

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

NCT06617793

Phase 1/2 Recruiting 28 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.

Timeline

Start
2025-02-24
Primary completion
2030-10-01
Completion
2030-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject rapcabtagene autoleucel Cell therapy Intravenous

Indications