RecruitingPhase 1Phase 2NCT06617793

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

An Open-label, Multi-center, Phase 1/2 Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Participants With Relapsing Multiple Sclerosis With Breakthrough Disease Activity During Previous Treatment With a Highly Efficacious Therapy


Sponsor

Novartis Pharmaceuticals

Enrollment

28 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing YTB323, a type of CAR-T cell therapy (engineered immune cells designed to attack a specific target on immune cells), in people with relapsing multiple sclerosis (MS) — a condition where the immune system mistakenly attacks the nervous system. The therapy involves re-engineering a patient's own immune cells to reduce the harmful immune response. **You may be eligible if...** - You are between 18 and 60 years old - You have been diagnosed with relapsing multiple sclerosis - Your disease has broken through (worsened) while you were on a strong MS medication like rituximab, ocrelizumab, natalizumab, ofatumumab, ublituximab, or alemtuzumab - You have had a recent relapse or new MRI changes showing disease activity - Your organ function is adequate **You may NOT be eligible if...** - Your MS has not shown breakthrough activity while on a high-efficacy therapy - You have serious kidney, liver, heart, or blood count issues - You have certain infections or immune conditions that could make this therapy dangerous Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALrapcabtagene autoleucel (YTB323)

CAR-T cell suspension for intravenous infusion


Locations(18)

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Nancy, France

Novartis Investigative Site

Rennes, France

Novartis Investigative Site

Bochum, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Ulm, Germany

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Córdoba, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Lausanne, Switzerland

Novartis Investigative Site

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06617793


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