Riyadh – BETH

The Saudi Food and Drug Authority (SFDA) has approved the first clinical trial of an innovative gene therapy developed locally using CAR T-cells to treat adult patients with acute lymphoblastic leukemia (ALL) positive for the CD19 protein, who have relapsed or failed to respond to previous treatments. The therapy will be administered through a closed-system process ensuring maximum safety standards.

The SFDA emphasized that this approval reflects its commitment to supporting advanced biotechnology clinical trials and enabling innovation in treating hard-to-cure diseases through an effective and transparent regulatory environment that accelerates access to promising therapies.

This milestone falls under the Healthcare Transformation Program – Vision 2030, which aims to position Saudi Arabia as a leading regional hub for research, development, and healthcare innovation.

The therapy, being tested for the first time in the Kingdom, was produced locally within an advanced manufacturing unit at King Faisal Specialist Hospital and Research Center in Riyadh, highlighting the synergy between regulatory and research institutions.

The investigational treatment involves reprogramming a patient’s own T-cells outside the body to specifically target cancer cells carrying the CD19 protein, before re-infusing them into the patient. The trial is primarily designed to assess the safety of the therapy in this early stage.

A team of scientists at King Faisal Specialist Hospital, in collaboration with Lentigen/Militony, is leading the development of this therapy using a closed manufacturing system. The therapy will be administered intravenously to patients aged 18–60 years.