Adaptimmune Therapeutics plc (ADAP) announced the U.S. FDA has accepted the company's investigational new drug application for autologous genetically modified T-cells expressing enhanced T cell receptors specific for MAGE A10 in patients with locally advanced or metastatic non-small cell lung cancer. The company said the the acceptance of IND allows it to initiate an open label Phase I/II study designed to evaluate MAGE-A10 T.
The company said the open label phase I/II dose escalating study of three doses of genetically engineered MAGE-A10 T-cells will assess the safety and tolerability of MAGE-A10 T. Secondary objectives will include the assessment of efficacy of MAGE-A10 T, measurements of durability of persistence of MAGE-A10 T-cells in the blood, and evaluations of the phenotype and functionality of MAGE-A10 T-cells.
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