Spain Approves First European-Developed CAR T-Cell Therapy for ALL

February 19, 2021

The Spanish Agency of Medicines and Medical Devices (AEMPS) recently approved a new chimeric antigen receptor (CAR) T-cell therapy to treat acute lymphoblastic leukemia (ALL) that is resistant to conventional treatments in patients older than 25. The therapy – called CAR-T ARI-0001 – is the first CAR T-cell therapy developed entirely in Europe to receive regulatory approval.

Investigators at the Hospital Clínic of Barcelona developed CAR-T ARI-0001 using a monoclonal antibody created at the hospital more than 30 years ago. In a clinical trial of 58 adult and pediatric patients, of whom 38 received the therapy, CAR-T ARI-0001 produced a complete response in more than 70% of patients. All had previously received several lines of treatment, and the vast majority had received a bone marrow transplant.

According to investigators, the preparation method used to obtain CAR-T ARI-0001 is “robust and reproducible,” which lowered the cost of production and made the therapy affordable for academic institutions and available to all patients. 

“The fact of producing it in our own hospital means that we can prepare it in a very short time, a fundamental aspect considering the fragility of many of these patients,” said Álvaro Urbano-Ispizua, MD, director of the Clinical Institute of Hemato-Oncological Diseases. “Furthermore, by having the product in our hands, we can modulate the amount of CAR Ts to administer or repeat the dose, if necessary.”