MB-CART2019.1 in Refractory Multiple Sclerosis

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.