Atara Biotherapeutics has recently received clearance from the U.S. Food and Drug Administration for an investigational new drug application for ATA3219. This therapy is an allogeneic, anti-CD19 chimeric antigen receptor T-cell monotherapy that targets systemic lupus erythematosus.
Phase 1 Study Focus
The upcoming Phase 1 study will primarily focus on assessing the safety and preliminary efficacy of ATA3219 in individuals with lupus nephritis. Subjects participating in this study will undergo lymphodepletion treatment before receiving ATA3219 infusion at varying doses - 40, 80, or 160 CAR+ T cells.
Monitoring Patients
ATA3219 is uniquely designed to be administered as a one-time infusion, allowing for continuous monitoring of safety and efficacy post-treatment. Each dose level is expected to enroll a small group of subjects, ranging from 3 to 6 patients per level. The enrollment process is set to begin in the latter half of 2024.
Promising Results
The IND submission for ATA3219 included compelling in vitro data demonstrating its CD19 antigen-specific functional activity and chimeric antigen receptor-mediated efficacy against B cells from SLE patients. Notably, ATA3219 showcased robust CD19-specific B-cell depletion in comparison to control groups.
This groundbreaking research paves the way for potential advancements in lupus treatment and offers hope for those affected by this challenging autoimmune condition.
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