Saudi Gazette report

RIYADH — 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, thanks to its years of collaborative efforts together with King Faisal Specialist Hospital and Research Centre (KFSHRC).

The therapy was 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.”

The SFDA said in a statement that 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 a 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 within the hospital's internal unit, which utilizes a closed transduction system. The treatment is administered to patients through intravenous infusion. The study's primary aim is to confirm the safety of the product in adult patients aged between 18 and 60 years.

The SFDA affirmed 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.