The head of global research and executive vice president of Atara Biotherapeutics discussed the upcoming study evaluating ATA188.
"This is a first in class cell therapy in multiple sclerosis. What's so critical, going back to the Hippocratic oath that we all sign up for as physicians is, first and foremost, do no harm. So, the safety profile here is critical."
Part 2 of a study evaluating ATA188 (NCT03283826) safety/tolerability, product kinetics, and biological and clinical effect in adults with progressive forms of multiple sclerosis (MS) is now underway.
The design of part 2 of the phase 1, multicenter double-blind, placebo-controlled study was presented by Amit Bar-Or, MD, FRCP, FAAN, FANA, professor, and chief, MS Division, Perelman School of Medicine; director, Center for Neuroinflammation and Neurotherapeutics; staff neurologist, University of Pennsylvania; and research scientist, Children’s Hospital of Pennsylvania at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2021, February 25-27.
The study will evaluate incidence of adverse events, change from baseline in cerebrospinal fluid (CSF) immunoglobulin G index, change from baseline in clinical disability on expanded disability status scale, Timed 25-Foot Walk, and/or 9-hole peg test, ambulatory activity monitoring, cervical spinal cord volume and whole brain volume on magnetic resonance imaging, the number of gadolinium-enhancing and new or enlarging T2 lesions on brain MRI scans. Other exploratory end points include assessment of potential biomarkers such as oligoclonal bands in CSF, persistence of ATA188, and cytokine profiling in blood and CSF compartments.
NeurologyLive spoke with Jakob Dupont, MD, MA, head of global research and executive vice president, Atara Biotherapeutics, the company that is developing ATA188, to learn more about the potential first-in-class cell therapy for MS. He also discussed the upcoming study’s design.
For more coverage of ACTRIMS Forum 2021, click here.