Atara Biotherapeutics Receives FDA Clearance of IND Application in Lupus Nephritis for ATA3219, an Allogeneic CAR T Therapy

Core Insights - Atara Biotherapeutics has received FDA clearance for an Investigational New Drug (IND) application for ATA3219, a novel allogeneic CAR T-cell therapy targeting systemic lupus erythematosus (SLE) with kidney involvement [1][2] - The company aims to address the unmet medical need in lupus nephritis through a Phase 1 clinical trial, which will evaluate the safety and preliminary efficacy of ATA3219 [2][3] Company Overview - Atara Biotherapeutics specializes in T-cell immunotherapy, focusing on developing off-the-shelf therapies for cancer and autoimmune diseases [1][7] - The company has extensive clinical experience, having treated over 600 patients with its allogeneic T-cell platform [2][6] - Atara is the first company to receive regulatory approval for an allogeneic T-cell immunotherapy, emphasizing its innovative approach [7] Product Details - ATA3219 is designed as a one-time infusion therapy that utilizes allogeneic Epstein-Barr virus (EBV) sensitized T cells expressing a CD19 CAR construct [5][6] - The therapy aims to provide a best-in-class profile with off-the-shelf availability, reducing the need for leukapheresis and long waiting times associated with autologous therapies [3][5] - Early academic data showed promising results, with 100% of lupus nephritis patients achieving drug-free, durable remission using autologous CD19 CAR T therapy [3][9] Clinical Trial Information - The Phase 1 trial will be a multi-center, open-label, single-arm, dose-escalation study, with subjects receiving lymphodepletion treatment followed by varying doses of ATA3219 [2][3] - The first patient is expected to be enrolled in the second half of 2024, with each dose level designed to enroll 3-6 patients [2][3] Market Context - Lupus nephritis is a serious complication of systemic lupus erythematosus, affecting over 200,000 patients in the U.S., with up to 60% of adult SLE patients developing renal disease [4] - Current therapies for lupus nephritis have suboptimal responses and limitations, highlighting the need for innovative treatments like ATA3219 [3][4]