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MB-CART2019.1 in Refractory Multiple Sclerosis

An Open Label Phase I/IIa, Multicenter, Interventional Single-arm Trial of MB-CART 2019.1 in Patients With Refractory Multiple Sclerosis (MS)

NCT07178431•Miltenyi Biomedicine GmbH

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART2019.1 in patients with active refractory primary and secondary Multiples Sclerosis. During the treatment, the patients will undergo a leukapheresis, a lymphodepleting chemotherapy and an administration of the expanded MB-CART2019.1. Phase I is to establish the safety and tolerability of MB-CART2019.1 and to determine a recommended dose for phase IIa (RP2D). During Phase IIa the treatment response after infusion of MB-CART2019.1 as defined by NEDA-3 ("no evident disease activity") will be evaluated. Therefore a BOIN trial design will be used to guide dose escalation and de-escalation decisions in phase I. The second phase will evaluate the efficacy and safety in patients treated with the recommended dose from phase I. The phase II part follows a Simon's 'minimax' two stage design.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Individuals must meet all of the following criteria to be included in the trial:
•1. Have read, understood and signed/dated the informed consent form.
•2. Age ≥18 years at the time of screening.
•3. Diagnosis of multiple sclerosis fulfilling the 2017 McDonald criteria.
•4. Progressive or worsening MS according to 2014 Lublin MS phenotypic criteria
•5. Disease activity despite treatment:
•1. Definition for RRMS/SPMS:
•1 or more relapses or an EDSS deterioration in the previous year (1 point or more if EDSS is between 3 and 5.5; 0.5 point or more if EDSS 6-6.5) or MRI activity (presence of at least 2 new/enlarging T2 lesions or T1CE lesions) despite on/previous treatment with an escalation therapy drug (i.e. natalizumab, ofatumumab, ocrelizumab, alemtuzumab or mitoxantrone) for at least 6 months.
•2. Definition for PPMS:
•EDSS deterioration in the previous year (1 point or more if EDSS between 3 and 5.5; 0.5 point or more if EDSS 6-6.5) or MRI activity (presence of at least 2 new/enlarging T2 lesions or T1CE lesions) despite on/previous treatment with ocrelizumab (treatment duration ≥ 6 months).
+22 more criteria

Exclusion Criteria

•Patients will be entered into this trial only if they meet none of the following criteria:
•1. 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.
•Only applicable for progressive MS (PPMS/SPMS), where the disease duration is longer than 15 years.
•2. History of a malignancy unless disease free for ≥5 years with the exception of basal or squamous cell skin cancer
•3. Known history of and/or active infection with hepatitis B (hepatitis B surface antigen positive)
•4. Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction (PCR) negative
•5. Any active uncontrolled bacterial, viral or fungal infection
•6. A history of and/or active infection with human immunodeficiency virus (HIV)
•7. A history of active or latent tuberculosis (TB); TB testing should be performed at screening (Quantiferon test). Confirmed active or latent TB the patient can be re-screened after full completion of anti-tuberculosis treatment (9 months of Isoniazide therapy)
•8. History of neuromyelitis optica spectrum disorder (NMOSD) or MOG antibody associated disease.
+17 more criteria

Locations (1)

Charité Universitätsmedizin Berlin

Berlin, Germany

Key Dates

Start Date

January 30, 2026

Primary Completion Date

February 28, 2030

Completion Date

December 30, 2030

Last Updated

November 21, 2025

Enrollment

ESTIMATED participants

Conditions

Multiple SclerosisCAR T Cell Therapy

Interventions

MB-CART2019.1

BIOLOGICAL

Contacts

Clinical Trial Manager

CONTACT

+4922048306820 clinicaltrials.gov@miltenyi.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MB-CART2019.1 in Refractory Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

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