1st MS patient dosed with Autolus’ CAR T-cell therapy in Phase 1 trial
Obe-cel approved in US, EU for type of blood cancer
The first patient has been dosed in a Phase 1 clinical trial of Autolus Therapeutics‘ experimental CAR T-cell therapy, obecabtagene autoleucel (obe-cel), in people with progressive forms of multiple sclerosis (MS) who have failed to respond to existing treatments.
Dosing took place at University College London Hospitals NHS Foundation Trust, in the U.K. The BOBCAT trial (NCT07139743) is evaluating the safety and tolerability of obe-cel, as well as its potential to slow disability progression.
Obe-cel being studied for other diseases
Obe-cel is approved as Aucatzyl in the U.S. and Europe for a type of blood cancer called B-cell acute lymphoblastic leukemia. It is also being studied for other diseases caused by abnormal or overactive B-cells, which are immune cells with a key role in driving MS and other autoimmune diseases.
“Dosing the first patient … is an important milestone for Autolus and the MS community,” Matthias Will, MD, chief development officer of Autolus, said in a company press release. “Given obe-cel’s well-characterized safety profile having been studied in more than 400 patients to date, we are hopeful about the impact this therapy can have for this patient population.”
Wallace Brownlee, MD, the neurologist leading the BOBCAT clinical study, said obe-cel could offer a one-time therapeutic approach for patients with progressive forms of MS.
“This is an extremely exciting prospect, and I look forward to participating in the study so we can explore obe-cel’s potential,” Brownlee added.
While more than 20 therapies are now approved for MS, most are indicated for relapsing forms of the disease. Medications for progressive MS are much more limited, and few therapies exist for patients who continue to progress despite being on highly effective agents.
Obe-cel belongs to a class of treatments known as CAR T-cell therapies. These involve collecting a person’s immune T-cells, modifying them in the lab to produce a man-made receptor that recognizes a specific target, and then infusing them into the patient’s bloodstream.
Obe-cel is specifically made with a person’s own T-cells, which are engineered to produce a chimeric antigen receptor (CAR) that binds to the CD19 protein on the surface of B-cells. When infused back into the patient, the modified CAR T-cells can attach to B-cells and destroy them, thereby easing the autoimmune attacks in MS.
“We believe obe-cel’s mechanism of action … makes [it] well-suited to address aberrant inflammatory and immune pathways [in progressive MS],” Will said.
The ongoing BOBCAT study plans to include up to 18 adults with progressive MS who have not responded to at least two highly effective disease-modifying therapies. Its main goal is to see if obe-cel is safe and well tolerated, and whether patients experience any dose-limiting toxicities within 28 days after the infusion.
Researchers will watch for changes in Expanded Disability Status Scale scores over two years. Changes in walking function, hand dexterity, and cognition will also be assessed.
About the Author
