CAR T-Cell Database

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In a mid-March meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health (NIH) Office of Biotechnology Activities, FDA presented a proposal to pilot databases of safety and CMC information from investigational new drug (IND) applications for a promising class of cancer immunotherapies called anti-CD19 chimeric antigen receptor (CAR) modified T-cells (CAR T-cells). In a presentation at the end of the second day of the meeting, Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies medical officer Maura O’Leary explained that Anti-CD19 CAR T-cells were chosen for the pilot based on the number of INDs available (36), as well as preliminary evidence that the products have the potential for substantial benefits as well as substantial risks. Risks include a potentially life-threatening complication called cytokine release syndrome (CRS), neurologic toxicity, and an increased risk for infection. The complex process for producing a T-cell therapy includes an apheresis to collect the patient’s autologous cells, which are then activated, transduced with an anti-tumor T-cell receptor, and then expanded ex-vivo and infused back into the patient. Through the pilot, FDA hopes to look across IND CMC data is to identify certain steps in the manufacturing process that might significantly influence a product’s safety, and evaluate the feasibility using such databases for other types of products. [For more on the CMC issues surrounding cell/gene therapies, see IPQ Monthly Update, March 2015.]
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