Actively Recruiting
MB-CART2019.1 in Refractory Multiple Sclerosis
Led by Miltenyi Biomedicine GmbH · Updated on 2026-05-11
26
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this trial is to assess the feasibility, safety and preliminary efficacy of MB-CART2019.1 in patients with active refractory primary and secondary progressive MS.
CONDITIONS
Official Title
MB-CART2019.1 in Refractory Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening
- Diagnosis of multiple sclerosis fulfilling the 2017 McDonald criteria
- Progressive or worsening MS according to 2014 Lublin MS criteria
- Disease activity despite treatment with escalation therapy drugs for at least 6 months
- Evidence of intrathecal IgG production through oligoclonal bands in cerebrospinal fluid for PPMS or SPMS
- Fully vaccinated against Hepatitis B
- Presence of varicella-zoster virus antibodies or at least one dose of Shingrix vaccine 4 weeks prior to treatment
- Presence of anti Epstein-Barr virus antibodies
- Adequate blood counts and lab parameters (neutrophils, platelets, lymphocytes, serum IgG, hemoglobin)
- Adequate renal, hepatic, pulmonary, and cardiac function
- Negative tests for hepatitis B and C core antibodies, CMV, VZV, herpes simplex virus 1 and 2 antibodies
- Negative tests for Myelin-Oligodendrocyte-Glycoprotein and Aquaporin-4 autoantibodies
- Women of childbearing potential and men with partners of childbearing potential must use highly effective contraception from consent until 12 months after treatment
- Willingness and ability to comply with all trial procedures
- Adequate vital signs
You will not qualify if you...
- Disability status greater than 7.0 on EDSS or age over 55 years
- Disease duration over 15 years for progressive MS
- History of malignancy unless disease-free for 5 years (except certain skin cancers)
- Known or active infection with hepatitis B or C virus unless treated
- Active uncontrolled bacterial, viral, or fungal infection
- History or active infection with HIV
- History or latent tuberculosis unless fully treated
- History of neuromyelitis optica spectrum disorder or MOG antibody disease
- History of CNS or spinal cord tumor, metabolic or infectious myelopathy, inherited CNS disorder, sarcoidosis, or non-MS neurological condition affecting study assessments
- History of cytopenia consistent with myelodysplastic syndrome
- History of sickle cell anemia or other hemoglobinopathies
- Primary immune deficiency disease
- Positive antiphospholipid antibodies or lupus anticoagulant
- Moderate or worse renal impairment
- Inflammatory diseases of the gastrointestinal tract that increase risk of perforation
- Certain severe cardiac conditions including recent heart failure or arrhythmias
- Recent use of systemic corticosteroids or T cell targeting drugs prior to leukapheresis
- Previous CAR T cell therapy
- Live vaccines within 30 days prior to leukapheresis
- Hypersensitivity to drugs used in trial procedures
- Contraindications to trial procedures as judged by investigator
- Pregnant or breastfeeding females or unwillingness to use birth control as required
- Participation in another interventional trial
- Inability to understand trial procedures and risks
- Other contraindications as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
Research Team
C
Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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