Model-informed drug development of autologous CAR-T cell therapy: Strategies to optimize CAR-T cell exposure leveraging cell kinetic/dynamic modeling


Extensive literature review conducted by a collaborative team at Pharmetheus and the MD Anderson Cancer Center to identify actionable variables – design elements in CAR-T cell discovery, development, and clinical practice – that could be modified to optimize CAR-T cell exposure within a well-informed model-informed drug development (MIDD) program.

Autologous chimeric antigen receptor (CAR)-T cell therapy is a novel therapeutic modality, in which a patient’s own immune cells are collected, genetically modified to target the patient’s tumor cells, and then re-infused into the patient’s body.

“This therapy has significantly transformed the treatment of aggressive hematological malignancies.” explains Anna Mc Laughlin, “However, despite its success, up to 60% of patients do not respond long-term. Alternative approaches beyond dose titration are required to increase exposure”

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