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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
Led by Novartis Pharmaceuticals · Updated on 2026-05-29
28
Participants Needed
18
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and behavior of YTB323 in people with Relapsing Multiple Sclerosis (RMS) who have shown disease activity despite previous treatment with strong therapies. This is an open-label, multi-center study involving about 28 participants and uses a dose-escalation design with initial small groups followed by a larger expansion group. All participants will receive one dose of YTB323, a CAR-T cell therapy given by intravenous infusion. Different groups may receive higher doses if lower doses are found to be safe. The study lasts 2 years, followed by an additional 13-year long-term follow-up to monitor ongoing effects and safety. Participants will undergo regular assessments including disability measures like the Expanded Disability Status Scale and walking tests, MRI scans to check brain lesions, and blood tests to study drug levels and immune responses. Researchers will closely monitor adverse events and serious side effects from the day of treatment through the 2-year study period. Safety and disease activity will be tracked throughout this time and beyond during long-term follow-up.
CONDITIONS
Brief 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 able to communicate well with the investigator and comply with study requirements
- Adequate kidney, liver, heart, blood, and lung function
- Male or female aged 18 to 60 years at screening with Relapsing Multiple Sclerosis diagnosis per 2017 McDonald criteria
- Evidence of recent breakthrough disease activity within 1 year while on highly efficacious therapy for at least 6 months or within 2 years after latest alemtuzumab infusion
- Breakthrough disease activity defined by confirmed clinical relapse or specific MRI lesion criteria
- Ambulatory patients with EDSS score between 3 and 6 (outside relapse)
- Disease duration less than 15 years
- Current or planned receipt of all recommended vaccinations for immunocompromised patients at least 6 weeks before lymphodepletion
You will not qualify if you...
- Diagnosis of primary progressive multiple sclerosis at screening
- History or current significant CNS disease or neurological disorders mimicking MS
- Significant cardiovascular, neurological, psychiatric, pulmonary, renal, liver, endocrine, metabolic, blood, or gastrointestinal disorders that may impact safety or study participation
- Blood donation or loss of more than 400 mL within 3 months prior to screening
- Previous stem cell therapy, organ transplant, or gene therapy
- Contraindications to lumbar puncture, including spine abnormalities or bleeding risks
- Use of anticoagulants except low-dose aspirin or ibuprofen
- Unable or unwilling to undergo MRI due to claustrophobia or contraindications such as metallic implants
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 years
Participants receive one dose of YTB323 and are monitored for safety and efficacy.
Regular visits during treatment period for assessments and monitoring
Duration - 13 years
Participants are followed for an additional 13 years to monitor long-term safety and outcomes after treatment.
Periodic follow-up visits over 13 years
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
N
Novartis Pharmaceuticals
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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