NCT07178431

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)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Miltenyi Biomedicine GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• CAR T Cell Therapy

Interventions

Type	Name	Description
BIOLOGICAL	MB-CART2019.1	CAR T cell therapy

Timeline

• Start date: 2026-01-30
• Primary completion: 2030-02-28
• Completion: 2030-12-30
• First posted: 2025-09-17
• Last updated: 2025-11-21

Locations

1 site across 1 country: Germany