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Autolus Therapeutics Announces First Patient Dosed in Phase 1 Trial of Obecabtagene Autoleucel (Obe-Cel) in Patients with Progressive Multiple Sclerosis
Globenewswire· 2025-10-20 11:00
Core Insights - Autolus Therapeutics has initiated the Phase 1 BOBCAT trial for its CAR T cell therapy, obecabtagene autoleucel (obe-cel), targeting progressive multiple sclerosis (PMS) patients, marking a significant milestone for both the company and the MS community [1][3] Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T cell therapies for cancer and autoimmune diseases, utilizing proprietary T cell programming technologies [6] - The company has a marketed therapy, AUCATZYL®, and a pipeline of candidates for treating hematological malignancies, solid tumors, and autoimmune diseases [6] Product Details - Obe-cel is a CD19-directed CAR T cell therapy designed to minimize excessive activation of T cells through a fast target binding off-rate, currently under investigation for progressive forms of multiple sclerosis [4][7] - The therapy has been previously approved for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) [8][9] Clinical Trial Insights - The Phase 1 BOBCAT trial will include up to 18 adult patients and aims to evaluate the safety, tolerability, and preliminary efficacy of obe-cel in patients with refractory progressive forms of multiple sclerosis [2] - The primary endpoint of the trial is to assess the safety and tolerability of obe-cel, with preliminary efficacy data being collected based on standard efficacy measures [2] Market Context - Multiple sclerosis is a chronic inflammatory autoimmune disease affecting approximately 1,000,000 individuals in the US, with around 30% suffering from progressive forms of the disease, highlighting a significant unmet need for effective treatments [5] - Current treatment options for progressive MS are limited, particularly for patients whose conditions continue to deteriorate despite existing therapies [2][5]