MB-CART2019.1 in Refractory Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMiltenyi Biomedicine GmbH
About this trial
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.
Eligibility criteria
Qualifiers
Have read, understood and signed/dated the informed consent form.
Age ≥18 years at the time of screening.
Diagnosis of multiple sclerosis fulfilling the 2017 McDonald criteria.
Progressive or worsening MS according to 2014 Lublin MS phenotypic criteria
Disqualifiers
For relapsing and progressive MS forms: the disability status according to the EDSS scale is larger than 7.0 or the age is larger than 55 years.
History of a malignancy unless disease free for ≥5 years with the exception of basal or squamous cell skin cancer
Known history of and/or active infection with hepatitis B (hepatitis B surface antigen positive)
Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction (PCR) negative
Trial design
Treatments tested in this trial
- MB-CART2019.1
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov