As a result of years of collaborative efforts with King Faisal Specialist Hospital and Research Centre (KFSHRC), the Saudi Food and Drug Authority (SFDA) has approved the registration of the first-of-its-kind clinical study (Phase I) of an investigational gene therapy, developed in Saudi Arabia, using Chimeric Antigen Receptor T-cells (CAR T-cells), under the title: “Phase I Study of Chimeric Antigen Receptor (CAR) T-cells in Adult Patients with Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia (ALL), Using a Closed Transduction System.”
Acute Lymphoblastic Leukemia (ALL) is a rapidly progressing cancer of the blood and bone marrow that affects lymphoid white blood cells. It causes the bone marrow to produce large number of immature lymphoblasts, which crowd out normal cells and impair the body’s ability to fight infections, transport oxygen, and control bleeding.
The investigational treatment is being developed by a team of scientists and researchers at KFSHRC, in collaboration with Lentigen/Miltenyi Company, and manufactured at the hospital within an internal unit that uses a closed transduction system. The treatment is administered to patients through intravenous infusion. The study’s primary aim is to confirm the product’s safety in adult patients aged 18 to 60 years.
The SFDA affirms that this approval is part of its commitment to supporting clinical studies and attracting the latest scientific innovations, especially for complex diseases. This is achieved through an effective and transparent regulatory environment that helps accelerate patient access to breakthrough therapies. This step also aligns with the objectives of the Health Sector Transformation Program, a key initiative of Saudi Vision 2030, which aims to position the Kingdom as a leading regional hub for research, development, and health innovation.
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