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An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis
Led by Novartis Pharmaceuticals · Updated on 2026-03-30
28
Participants Needed
18
Research Sites
292 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to communicate and comply with study requirements
- Adequate kidney, liver, heart, blood, and lung function
- Male or female aged 18 to 60 years at screening
- Diagnosis of Relapsing Multiple Sclerosis according to 2017 McDonald criteria
- Evidence of breakthrough disease activity within 1 year while on a highly effective therapy (rituximab, ocrelizumab, natalizumab, ofatumumab, ublituximab) or within 2 years after last alemtuzumab infusion
- Evidence of breakthrough disease activity defined as a confirmed clinical relapse or persistent MRI activity (≥2 T1 gadolinium-enhancing lesions on one MRI, ≥1 T1 gadolinium-enhancing lesion on two or more MRIs, or ≥2 new T2 lesions within 1 year)
- Ambulatory patients with EDSS score between 3 and 6 (inclusive) outside of relapse
- Disease duration less than 15 years
- Current on all recommended vaccinations for immunocompromised patients at least 6 weeks before lymphodepletion
You will not qualify if you...
- Diagnosis of primary progressive multiple sclerosis (PPMS)
- History or current significant CNS disease such as stroke, traumatic brain or spinal injury, myelopathy, or neurological disorders that mimic MS or ICANS
- Significant cardiovascular disease including recent myocardial infarction, unstable heart disease, severe heart failure, arrhythmia, or uncontrolled hypertension within 6 months
- Other neurological disorders besides MS including seizure disorders
- Psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological, or gastrointestinal diseases that could affect safety or study participation
- Blood donation or loss of >400 mL blood within 3 months before screening
- Previous stem cell therapy, organ transplant, or gene therapy
- Contraindications to lumbar puncture such as spinal abnormalities, bleeding risks, or use of anticoagulants (except low-dose aspirin or ibuprofen)
- Unable or unwilling to undergo MRI scans due to claustrophobia or absolute contraindications like metallic implants or pacemakers
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 18 locations
1
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
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2
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
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3
Novartis Investigative Site
Montpellier, France, 34090
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4
Novartis Investigative Site
Nancy, France, 54035
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5
Novartis Investigative Site
Rennes, France, 35033
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6
Novartis Investigative Site
Bochum, Germany, 44791
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7
Novartis Investigative Site
Essen, Germany, 45147
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8
Novartis Investigative Site
Mainz, Germany, 55131
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9
Novartis Investigative Site
Ulm, Germany, 89081
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10
Novartis Investigative Site
Genova, GE, Italy, 16132
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11
Novartis Investigative Site
Milan, MI, Italy, 20132
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12
Novartis Investigative Site
Barcelona, Spain, 08035
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13
Novartis Investigative Site
Córdoba, Spain, 14004
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14
Novartis Investigative Site
Madrid, Spain, 28034
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15
Novartis Investigative Site
Valencia, Spain, 46026
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16
Novartis Investigative Site
Bern, Switzerland, 3010
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17
Novartis Investigative Site
Lausanne, Switzerland, 1011
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18
Novartis Investigative Site
Zurich, Switzerland, 8091
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Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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