Atara Biotherapeutics, Inc. announced its recent submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN). ATA3219 is an allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. Proof of concept for a CD19 CAR T approach in autoimmune disease was first demonstrated in early academic results from an investigator-sponsored study showing 100% (8/8) of LN patients rapidly attaining drug-free, durable remission with an autologous CD19-targeted CAR T therapy.

The therapy eliminated the pathogenic, autoreactive B cells and allowed healthy B cells to return after treatment, enabling the patients' immune system to function normally again with associated improvement of clinical symptoms. Unlike gene-edited approaches aimed at inactivating T-cell receptor (TCR) function to reduce the risk for graft-vs-host disease, EBV T cells maintain expression of native TCRs that promote in vivo functional persistence while also demonstrating inherently low alloreactivity due to their recognition of defined viral antigens and partial human leukocyte antigen (HLA) matching. A molecular toolkit of clinically-validated technologies--including the 1XX costimulatory domain designed for better cell fitness and less exhaustion while maintaining stemness-- offers a differentiated approach to addressing significant unmet need with the next generation CAR T.