SFDA Approves First-of-its-Sort Medical Trial for a Gene Remedy Developed in Saudi Arabia to Deal with Acute Lymphoblastic Leukemia (ALL)
KFYousef
Thu, 08/28/2025 – 15:35
On account of years of collaborative efforts with King Faisal Specialist Hospital and Analysis Centre (KFSHRC), the Saudi Meals and Drug Authority (SFDA) has permitted 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), underneath the title: “Part I Research of Chimeric Antigen Receptor (CAR) T-cells in Grownup Sufferers with Relapsed/Refractory CD19 Constructive 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 giant variety of immature lymphoblasts, which crowd out regular cells and impair the physique’s means to combat infections, transport oxygen, and management bleeding.
The investigational remedy is being developed by a workforce 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 major intention is to verify 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 newest scientific improvements, particularly for complicated ailments. That is achieved by means of an efficient and clear regulatory surroundings 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, improvement, and well being innovation.
To view the listing of registered medical research, please go to the SFDA’s web site:
