Atara asks FDA to clear ATA3219 for clinical testing in lupus nephritis

Therapy is an experimental CAR-T cell therapy that uses engineered donor cells

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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Atara Biotherapeutics has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for permission to test ATA3219, a CAR T-cell therapy, in clinical trials involving systemic lupus erythematosus (SLE) patients with lupus nephritis.

CAR T-cell therapies are based on immune T-cells, which are obtained from patients or healthy donors. T-cells are engineered to be equipped with a lab-made receptor, called chimeric antigen receptor (CAR), that lets them recognize a specific disease-associated protein.

With ATA3219, T-cells obtained from healthy donors are engineered to target CD19, a protein on the surface of most B-cells, which produce the autoantibodies that drive SLE.

The IND submission includes lab data that shows ATA3219 targeted and almost completely eliminated CD19-specific B-cells from people with SLE.

“We look forward to working with the FDA to initiate this study and advance ATA3219 into the clinic to potentially bring a new disease-modifying option for patients suffering from this chronic disease,” Rajani Dinavahi, MD, chief medical officer at Atara, said in a company press release.

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What is ATA3219?

In SLE, the most common form of lupus, B-cells produce harmful antibodies that target and attack healthy tissue, causing inflammation. This can result in a wide range of symptoms, depending on the tissues and organs affected.

Lupus nephritis is a common SLE complication that features inflammation and kidney damage. Common therapeutic approaches involve immunosuppressants. Up to 70% of patients with lupus nephritis are refractory, or fail to respond to standard treatment, however.

“Despite therapeutic advances, there remains high unmet need in lupus nephritis, where standard of care and approved therapies have limited efficacy that often rely on multiyear, if not lifelong immune suppression,” Dinavahi said.

ATA3219 is an experimental CAR-T cell therapy that uses allogeneic, or donor-derived T-cells, specifically engineered to target the CD19 protein on the surface of B-cells and involved in B-cell mediated autoimmune diseases.

T-cells are obtained from healthy donors and then primed to attack cells infected by the Epstein-Barr virus (EBV), one of the most common human viruses that’s present in almost all adults over age 40. These EBV T-cells can then be modified to target several non-EBV-associated diseases.

Donor-derived T-cells can be preserved for when they’re needed and cells from a single donor can be used in several patients, enabling the rapid treatment of high-risk patients.

According to the company, using a donor-based approach may address the significant technical, manufacturing cost, and access challenges seen with autologous CAR T-cell products where the patients’ own immune T-cells are used.

“We are particularly excited to bring this allogeneic CD19 CAR T to the clinic as it has been designed to offer a differentiated profile by incorporating multiple clinically validated attributes,” said Cokey Nguyen, PhD, Atara’s chief scientific and technical officer. “Our goal is to demonstrate that ATA3219 can provide deep and durable remission, allowing the immune system to reset and potentially transform a new therapeutic area with an off-the-shelf CAR T approach.”

ATA3219 is also being tested in a Phase 1 clinical trial (NCT06256484) that’s enrolling adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma, a type of cancer.

It will assess the cell therapy’s safety and tolerability, as well as its preliminary efficacy in this patient population. Its launch follows the approval of an IND Atara submitted to the FDA for this condition last year.