Actively Recruiting
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)
Led by Novartis Pharmaceuticals · Updated on 2025-11-20
28
Participants Needed
17
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 18 to 60 years (inclusive) at screening.
- Signed informed consent must be obtained prior to participation.
- Able to communicate well with the investigator and comply with study requirements.
- Able to undergo lumbar puncture, blood draws, tolerate brain and spinal MRI, and participate in all study procedures.
- Diagnosis of secondary progressive MS (SPMS) or primary progressive MS (PPMS) confirmed by 2017 McDonald criteria.
- Less than 15 years since first MS symptoms.
- Ambulatory with EDSS score between 3 and 6.5.
- Evidence of disease progression of at least 1.00 on EDSS within the last 24 months.
- No relapse in the last 24 months.
- No Gd-enhancing lesions on brain or spinal cord MRI at screening.
- Up to date with all recommended vaccinations for immunocompromised patients at least 6 weeks before lymphodepletion.
You will not qualify if you...
- Diagnosis of relapsing MS or active progressive MS at screening.
- History or current significant CNS diseases other than MS, including stroke, brain or spinal injury, myelopathy, seizures, or epilepsy.
- Significant cardiovascular disease within 6 months prior to or during screening.
- History of confirmed Progressive Multifocal Leukoencephalopathy (PML) or symptoms consistent with PML.
- Clinically significant active or chronic infections, including hepatitis B or C.
- Blood donation or loss of more than 400 mL within 3 months before screening.
- Prior stem cell therapy, organ transplantation, or gene therapy.
- Contraindications to lumbar puncture (e.g., structural spine abnormalities, bleeding risks, certain anticoagulants).
- Inability or unwillingness to have MRI scans due to claustrophobia or contraindications.
- Pregnant or nursing women.
- Past splenectomy.
- Active or latent tuberculosis infection.
- Significant psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological, or gastrointestinal disorders that may affect safety or study compliance.
- Recent thromboembolic event or coagulation disorders requiring chronic anticoagulation or antiplatelet therapy (except low-dose aspirin or ibuprofen).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
2
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Actively Recruiting
3
Novartis Investigative Site
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
4
Novartis Investigative Site
Bron, France, 69677
Actively Recruiting
5
Novartis Investigative Site
Montpellier, France, 34090
Actively Recruiting
6
Novartis Investigative Site
Nancy, France, 54035
Actively Recruiting
7
Novartis Investigative Site
Rennes, France, 35033
Actively Recruiting
8
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
9
Novartis Investigative Site
Ulm, Germany, 89081
Actively Recruiting
10
Novartis Investigative Site
Genova, GE, Italy, 16132
Actively Recruiting
11
Novartis Investigative Site
Milan, MI, Italy, 20132
Actively Recruiting
12
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
13
Novartis Investigative Site
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
14
Novartis Investigative Site
Málaga, Spain, 29010
Actively Recruiting
15
Novartis Investigative Site
Bern, Switzerland, 3010
Active, Not Recruiting
16
Novartis Investigative Site
Lausanne, Switzerland, 1011
Actively Recruiting
17
Novartis Investigative Site
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here