Actively Recruiting
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-01-06
156
Participants Needed
22
Research Sites
510 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
I
Immune Tolerance Network (ITN)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
CONDITIONS
Official Title
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years, inclusive, at the time of screening
- Diagnosed with multiple sclerosis according to the 2017 McDonald Criteria
- Expanded Disability Status Scale (EDSS) score of 6.0 or less at randomization
- Brain MRI showing T2 abnormalities meeting criteria for MS dissemination in space
- Highly active, treatment-resistant relapsing MS with at least two disease activity episodes in the past 36 months
- At least one disease activity episode occurring after one month of treatment with an approved oral or monoclonal antibody disease-modifying therapy (DMT) or rituximab
- At least one disease activity episode within 12 months prior to screening
- At least one clinical MS relapse confirmed by a neurologist
- Eligibility for treatment with at least one high efficacy BAT DMT without prior use or contraindications
- Completed COVID-19 vaccination series at least 14 days before randomization
- Positive varicella zoster virus antibodies or received at least one dose of Shingrix vaccine at least 4 weeks before randomization
- Insurance approval for treatment with at least one candidate BAT DMT
- Ability to comply with study procedures and provide informed consent
- Adherence to contraception requirements if of childbearing potential
- Willingness to substitute Marinol if using marijuana and randomized to AHSCT
You will not qualify if you...
- Diagnosis of primary progressive MS
- History of neuromyelitis optica spectrum disorder or MOG antibody disease
- Prior treatment with investigational agents within 3 months or 5 half-lives
- Acute MS relapse or high-dose steroid treatment within one month prior to randomization
- Starting any BAT DMT between screening and randomization
- Brain MRI or cerebrospinal fluid findings indicating progressive multifocal leukoencephalopathy (PML)
- History or presence of blood disorders such as myelodysplastic syndrome, cytopenia, sickle cell anemia, or hemoglobinopathies
- Evidence or history of hepatitis B or C infection, cirrhosis, or significant liver disease
- Positive COVID-19 test within 14 days prior to randomization
- HIV infection
- Positive tuberculosis test
- Active infections including viral, bacterial, fungal, or parasitic
- Recent hospitalization for infections requiring intravenous treatment unless cleared
- Receipt of live vaccines within 6 weeks of randomization
- Significant heart disease including arrhythmias, coronary artery disease, heart valve disease, or low heart function
- Impaired kidney or lung function
- Poorly controlled diabetes
- History of cancer except certain localized skin cancers or cervical carcinoma in situ
- Moderate to severe autoimmune rheumatologic diseases requiring treatment
- Active peptic ulcer disease
- Prior autologous hematopoietic stem cell transplant or solid organ transplant
- Positive pregnancy test or breastfeeding
- Inability to accept irreversible sterility as a side effect
- Severe psychiatric illness or cognitive dysfunction interfering with consent
- Allergy to rabbit or E. coli proteins
- Metallic or electronic implants preventing MRI with gadolinium
- History of ischemic cerebrovascular disorders
- Other neurological or systemic autoimmune disorders affecting participation
- Any medical condition increasing treatment mortality risk or incompatible with trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Stanford Multiple Sclerosis Center
Palo Alto, California, United States, 94304
Actively Recruiting
2
Rocky Mountain Multiple Sclerosis Center, University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
4
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
5
University of Minnesota Multiple Sclerosis Center
Minneapolis, Minnesota, United States, 55455
Active, Not Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
John L. Trotter Multiple Sclerosis Center, Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Siinai
New York, New York, United States, 10029
Actively Recruiting
9
Rochester Multiple Sclerosis Center, University of Rochester
Rochester, New York, United States, 14620
Not Yet Recruiting
10
Duke University Medical Center
Durham, North Carolina, United States, 27710
Active, Not Recruiting
11
University of Cincinnati (UC) Waddell Center for Multiple Sclerosis
Cincinnati, Ohio, United States, 45219
Actively Recruiting
12
Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
Multiple Sclerosis Center, Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
14
Penn Comprehensive MS Center, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
University of Texas Southwestern Medical Center: Division of Multiple Sclerosis and Neuroimmunology
Dallas, Texas, United States, 75390
Actively Recruiting
16
Maxine Mesigner Multiple Sclerosis Comprehensive Care Center, Baylor College of Medicine Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
17
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
18
Virginia Commonwealth University Multiple Sclerosis Treatment and Research Center
Richmond, Virginia, United States, 23219
Actively Recruiting
19
Clinical Research Division, Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
20
Multiple Sclerosis Center, Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Actively Recruiting
21
Multiple Sclerosis Center at Northwest Hospital
Seattle, Washington, United States, 98133
Actively Recruiting
22
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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