An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Signed informed consent, and able to communicate well with the investigator and comply with the requirements of the study * Adequate renal, hepatic, cardiac, hematological, and pulmonary function * Male or female participants, ≥18 years to ≤60 years at screening, with diagnosis of RMS according to the 2017 McDonald diagnostic criteria Evidence of recent (i.e. within 1 year) breakthrough disease activity while at least 6 months on a highly efficacious therapy (any of the following): rituximab (Rituxan®), ocrelizumab (Ocrevus®), natalizumab (Tysabri®), ofatumumab (Kesimpta®), ublituximab (Briumvi®) or evidence of breakthrough disease activity within 2 years after the latest alemtuzumab infusion (Lemtrada®). Evidence of breakthrough disease activity is defined as one or more of the following: 1. Confirmed Clinical MS relapse 2. Persistent radiological activity defined by one of the following: * ≥2 T1 gadolinium-enhancing lesions on a single MRI scan * ≥1 T1 gadoliniu