SFDA Approves First-of-its-Type Scientific Trial for a Gene Remedy Developed in Saudi Arabia to Deal with Acute Lymphoblastic Leukemia (ALL)
KFYousef
Thu, 08/28/2025 – 15:35
Because of years of collaborative efforts with King Faisal Specialist Hospital and Analysis Centre (KFSHRC), the Saudi Meals and Drug Authority (SFDA) has authorized the registration of the first-of-its-kind medical examine (Part I) of an investigational gene remedy, developed in Saudi Arabia, utilizing Chimeric Antigen Receptor T-cells (CAR T-cells), beneath the title: “Part I Examine of Chimeric Antigen Receptor (CAR) T-cells in Grownup Sufferers with Relapsed/Refractory CD19 Optimistic Acute Lymphoblastic Leukemia (ALL), Utilizing a Closed Transduction System.”
Acute Lymphoblastic Leukemia (ALL) is a quickly progressing most cancers of the blood and bone marrow that impacts lymphoid white blood cells. It causes the bone marrow to provide massive variety of immature lymphoblasts, which crowd out regular cells and impair the physique’s potential to battle infections, transport oxygen, and management bleeding.
The investigational remedy is being developed by a group of scientists and researchers at KFSHRC, in collaboration with Lentigen/Miltenyi Firm, and manufactured on the hospital inside an inner unit that makes use of a closed transduction system. The remedy is run to sufferers by means of intravenous infusion. The examine’s main goal is to substantiate the product’s security in grownup sufferers aged 18 to 60 years.
The SFDA affirms that this approval is a part of its dedication to supporting medical research and attracting the most recent scientific improvements, particularly for complicated ailments. That is achieved by means of an efficient and clear regulatory setting that helps speed up affected person entry to breakthrough therapies. This step additionally aligns with the goals of the Well being Sector Transformation Program, a key initiative of Saudi Imaginative and prescient 2030, which goals to place the Kingdom as a number one regional hub for analysis, growth, and well being innovation.
To view the listing of registered medical research, please go to the SFDA’s web site:
