Autolus Therapeutics has administered the first dose to a participant in its Phase I BOBCAT trial, which is assessing obecabtagene autoleucel (obe-cel) for progressive multiple sclerosis (MS).
The treatment was delivered at University College London Hospitals NHS Foundation Trust (UCLH) in collaboration with University College London (UCL), which is a development partner for the therapy.
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The Phase I trial aims to recruit up to 18 adult participants to assess the preliminary efficacy, safety and tolerability of obe-cel in individuals with refractory progressive forms of multiple sclerosis.
Its primary endpoint will focus on safety and tolerability, while preliminary data will investigate biological effects and efficacy by measuring changes from baseline in standard efficacy metrics.
UCLH consultant neurologist and trial principal investigator Wallace Brownlee said: “Progressive MS is a debilitating disease, and there are limited treatment options available, particularly for those whose disease continues to deteriorate despite long-term treatment with currently available B-cell targeting therapies.
“Obe-cel’s CAR T mediated B-cell depletion approach holds the promise of suppressing both autoimmune and CNS-compartmentalised inflammatory pathways which play key roles in driving disease. If successful in clinical trials, obe-cel could transform outcomes for progressive MS patients with a one-time treatment.”
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By GlobalDataAutolus chief development officer Dr Matthias Will said: “Dosing the first patient in progressive MS is an important milestone for Autolus and the MS community.
“We believe obe-cel’s mechanism of action, underpinned by its unique fast-off rate CAR mechanism, makes obe-cel well-suited to address aberrant inflammatory and immune pathways for PMS patients.”
Obe-cel is a chimeric antigen receptor (CAR) T cell therapy targeting the B-lymphocyte antigen CD19.
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