By Chris Wack
Atara Biotherapeutics said the U.S. Food and Drug Administration has cleared an investigational new drug application for ATA3219, an allogeneic, anti-CD19 chimeric antigen receptor T-cell monotherapy for the treatment of systemic lupus erythematosus.
The Phase 1 study will evaluate the safety and preliminary efficacy of ATA3219 in subjects with lupus nephritis.
Subjects will receive lymphodepletion treatment followed by ATA3219 at a dose of 40, 80, or 160 CAR+ T cells. ATA3219 is designed to be given as a one-time infusion and followed for safety and efficacy.
Each dose level is designed to enroll 3-6 patients, with the first subject expected to be enrolled in the second half of 2024.
The ATA3219 IND submission included in vitro data reflecting the CD19 antigen-specific functional activity of ATA3219 and chimeric antigen receptor-mediated activity against B cells from SLE patients. ATA3219 led to robust CD19-specific B-cell depletion compared to controls.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
02-29-24 0935ET