Friends, Parker Institute call for more flexibility in early T cell therapy development
Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy recommend more flexible IND and manufacturing requirements and the use of adaptive clinical trials to advance development of emerging cellular therapeutics such as CAR T and engineered T cell receptor (TCR) therapies.
In a white paper, the institutions recommended early use of small, exploratory clinical studies to narrow down candidates and better understand cell biology, given the limited ability of animal models to predict safety and efficacy of T cell-based therapies. The authors suggested FDA expand its 2006 Exploratory IND guidance to include early clinical studies to investigate the safety, feasibility and mechanism of action of several closely related cell therapies...