Loading clinical trials...

RECRUITINGPHASE1/PHASE2

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

NCT06617793•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Detailed Description

All participants in this study will receive YTB323. Both the participant and the study doctor will know the participant is getting YTB323. Participants will be given one dose of YTB323. Different groups of participants may receive a higher dose of YTB323, if proven to be safe for every participant at the lower dose. Participants are in this study for 2 years and will be followed for an additional 13 years in a long-term follow up study. The main question this trial is designed to answer: Is YTB323 treatment safe for participants with relapsing MS?

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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 gadolinium-enhancing lesions on two or more separate MRI scans
•* ≥2 new T2 lesions compared to a previous scan within a period ≤1 year
•* Ambulatory patients (EDSS of 3 to 6 points, inclusive assessed outside of relapse)
+2 more criteria

Exclusion Criteria

•Diagnosis of primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria at screening
•History of or current clinically significant CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS or ICANS at screening
•Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 6 months prior to screening), neurological disorders other than MS (including seizure disorders even when well controlled), psychiatric, pulmonary (including, history of or active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis), renal, hepatic, endocrine, metabolic (e.g. severe hypoproteinemia due to nephrotic syndrome), hematological disorders or gastrointestinal disease that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant, prior to screening
•Have donated blood or experienced a loss of blood \> 400 mL within 3 months prior screening, or longer if required by local regulations
•Any prior stem cell therapy or organ transplantation or gene therapy
•Any contraindications to LP, including but not limited to:
•* Known or suspected structural abnormality of the lumbar spine that, in the opinion of the Investigator, may interfere with the performance of the LP, or increase the risk of the procedure for the participant
•* Presence of risk for increased or uncontrolled bleeding including, but not limited to, vascular abnormalities or neoplasms at or near the LP site, disorders of the coagulation cascade, platelet function, or platelet count
•Participants not willing or able to take MRI scans as per protocol. Unable to undergo MRI due to for example claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)

Locations (17)

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

Ulm, Germany

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Key Dates

Start Date

February 24, 2025

Primary Completion Date

October 1, 2030

Completion Date

October 1, 2030

Last Updated

February 20, 2026

Enrollment

ESTIMATED participants

Conditions

Relapsing Multiple Sclerosis

Interventions

rapcabtagene autoleucel (YTB323)

BIOLOGICAL

Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

NCT07426991

Multiple SclerosisRemitting-Relapsing Multiple Sclerosis+4 more

View study

RECRUITING

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

NCT06433752

Relapsing Multiple SclerosisMultiple Sclerosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)

Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study

Role of ADA SNPs in Subjects With Relapsing Multiple Sclerosis (RMS)

Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset