FDA Issues Comprehensive Guidance for Industry and Academic Sponsors Developing Ex Vivo-Manufactured CAR T Cell Products in Oncology: Expert Recommendations for CMC, Pharmacology, and Clinical Trial Design
The guide includes recommendations tailored to both autologous and allogeneic CAR T-cell products. In addition, it provides guidance on comparative analytical studies for CAR T-cell products. Although the focus is on CAR T-cell products, certain information and recommendations may also be relevant for other genetically modified lymphocyte products, such as CAR natural killer (NK) cells or T-cell receptor (TCR)-modified T-cells. It is important to note that for these related product types, further considerations beyond those suggested in this guidance may be required depending on the product and manufacturing process.