UANL to conduct Mexico's first domestic CAR-T cell clinical trial

The Mexican Federal Commission for Protection against Sanitary Risks (Cofepris) has authorized the first clinical trial in Mexico using domestically manufactured CAR-T cells. Developed by the Universidad Autónoma de Nuevo León (UANL), the study will be conducted at the Hospital Universitario ‘Dr. José Eleuterio González’.

The clinical trial, identified as protocol 7192, focuses on evaluating the safety and preliminary efficacy of the MB-CART19 therapy in adults with relapsed or refractory acute lymphoblastic leukemia. This specific type of cancer has either returned after previous treatment or has failed to respond to conventional therapies.

CAR-T therapy involves extracting a patient's own T-lymphocytes and genetically modifying them in a laboratory to recognize and attack cancer cells before re-administering them. Unlike previous methods, this process—including lymphocyte extraction, genetic modification, quality control, and administration—will be performed entirely within the hospital's facilities without relying on foreign manufacturing. This initiative aims to strengthen national capabilities in advanced treatments and help establish regulatory frameworks for advanced therapies in Mexico.