SFDA Approves First Gene Therapy Clinical Trial For Treating Acute Lymphoblastic Leukemia In Saudi Arabia

The Saudi Food and Drug Authority (SFDA) has approved a groundbreaking clinical trial for a gene therapy developed in Saudi Arabia. This Phase I study focuses on Chimeric Antigen Receptor T-cells (CAR T-cells) to treat relapsed or refractory CD19 positive acute lymphoblastic leukaemia (ALL) in adults. This approval marks a significant milestone in the country's medical research efforts.

Acute lymphoblastic leukaemia is an aggressive cancer affecting blood and bone marrow, primarily targeting lymphoid white blood cells. It leads to the overproduction of immature lymphoblasts, which hinders normal cell function. This condition compromises the body's ability to fight infections, transport oxygen, and control bleeding, making effective treatment crucial.

The investigational therapy is being developed by scientists at King Faisal Specialist Hospital and Research Centre (KFSHRC) in collaboration with Lentigen/Miltenyi Company. The treatment uses a closed transduction system and is manufactured within KFSHRC's internal unit. It is administered intravenously to patients, aiming to ensure safety for adults aged 18 to 60 years.

This clinical study aligns with Saudi Vision 2030's Health Sector Transformation Program. The program seeks to establish Saudi Arabia as a regional leader in research, development, and health innovation. By supporting such studies, the SFDA aims to foster an environment conducive to scientific advancements.

The SFDA emphasised its dedication to facilitating clinical research and embracing cutting-edge scientific innovations for complex diseases. Through transparent regulations, it aims to expedite patient access to new therapies. This initiative reflects the authority's commitment to enhancing healthcare outcomes in the Kingdom.

The primary goal of this Phase I study is to assess the safety of the CAR T-cell therapy in adult patients. The SFDA's approval underscores its role in promoting innovative treatments that address challenging medical conditions effectively.

For more information on registered clinical studies, interested parties can visit the SFDA's official website.

With inputs from SPA