RecruitingPhase 1Phase 2NCT06675864

Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS)

An Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression, and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS)


Sponsor

Novartis Pharmaceuticals

Enrollment

28 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, multi-center, non-confirmatory study to assess the safety, disease progression, and cellular kinetics following YTB323 administration to 28 participants with non-active Progressive Multiple Sclerosis (PMS). 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 study is testing a new cell therapy called YTB323 for people with progressive multiple sclerosis (MS) — the kind that slowly worsens over time without relapses. Researchers want to see if this treatment is safe and whether it can slow or stop disability progression. **You may be eligible if...** - You are 18–60 years old - You have been diagnosed with secondary progressive MS (SPMS) or primary progressive MS (PPMS) - Your MS has been getting worse in the past 2 years (disability increased) - You have not had a relapse in the last 2 years - You are able to walk, at least with assistance (disability score 3–6.5) - Your MS symptoms started no more than 15 years ago - You are up to date on recommended vaccines **You may NOT be eligible if...** - You have relapsing MS or actively inflamed (enhancing) lesions on MRI - You have had a prior stem cell transplant, gene therapy, or organ transplant - You have significant heart, lung, liver, kidney, or psychiatric conditions - You are pregnant or breastfeeding - You have an active or chronic infection (such as hepatitis B or C, or tuberculosis) - You are unable to have MRI scans or lumbar punctures 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALrapcabtagene autoleucel (YTB323)

CAR-T cell suspension for intravenous infusion


Locations(17)

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Bron, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Nancy, France

Novartis Investigative Site

Rennes, France

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Ulm, Germany

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Majadahonda, Madrid, Spain

Novartis Investigative Site

Málaga, Spain

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Lausanne, Switzerland

Novartis Investigative Site

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06675864


Related Trials