FDA clears new drug application for CAR T-cell therapy in SLE with lupus nephritis
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Key takeaways:
- ATA3219 is an allogeneic CAR T-cell therapy being investigated in the treatment of SLE with lupus nephritis.
- The drug is described as “a potentially curative off-the-shelf cell therapy.”
The FDA has cleared an investigational new drug application for an allogeneic anti-CD19 chimeric antigen receptor T-cell therapy for the treatment of systemic lupus erythematosus with lupus nephritis, according to the manufacturer.
The therapy, developed by Atara Biotherapeutics and currently known as ATA3219, is based on the company’s novel allogeneic Epstein-Barr virus T-cell platform and targets CD19+ relapsed or refractory B-cell malignancies. An investigational new drug application for ATA3219 was previously cleared in non-Hodgkin’s lymphoma, according to a press release from Atara.
“Expanding upon an extensive clinical experience encompassing the treatment of over 600 patients using our allogeneic T-cell platform in both oncology and autoimmune diseases, we are excited to clinically evaluate the potential of our differentiated allogeneic CAR T-cell approach,” Pascal Touchon, president and CEO of Atara, said in the release. “We look forward to bringing the promise and accessibility of a potentially curative off-the-shelf cell therapy option to patients with severe autoimmune diseases, potentially eliminating the burdens of autologous CAR T therapies like costly infrastructure and treatment delays.”
According to the company statement, the application included in vitro data showing ATA3219 produced “robust” CD19-specific B-cell depletion in patients with SLE compared with controls. An upcoming multicenter, open-label, single-arm, phase 1 dose escalation study will probe the safety and preliminary efficacy in patients with lupus nephritis, the release added.
“Existing therapeutic agents for lupus nephritis yield suboptimal responses and have limitations due to their requirement for ongoing administration, susceptibility to treatment failures, and limited accessibility to inflamed tissues resulting in incomplete depletion of B cells,” Rajani Dinavahi, MD, chief medical officer of Atara, said in the release. “CAR T cells can naturally infiltrate deep into target tissues to mediate B-cell depletion and produce durable responses.”
She described ATA3219 as “an off-the-shelf therapy that could significantly reduce constraints for patients and physicians like leukapheresis and long waiting times, therefore potentially improving access to a large population of patients.”
The FDA has previously cleared an investigational new drug application for Cabaletta Bio’s CABA-201, a 4-1BB-containing fully human CD19-CAR T-cell therapy, to be studied in patients with myositis, as well as a fast-track designation to the same drug for SLE and lupus nephritis. Another novel anti-CD19 CAR T-cell therapy for patients with refractory lupus nephritis, Kyverna’s KYV-101, has also been granted fast-track designation.
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