Atara Biotherapeutics Gets FDA Clearance for ATA3219 IND Application

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

February 29, 2024 09:35 ET (14:35 GMT)

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