Iovance Biotechnologies, Inc. (Sponsor) is carrying out this study to find out if an Investigational Medicinal Product (IMP) called LN-145 (referred to as “investigational product”) is safe and beneficial in the treatment of patients with recurrent and/or metastatic head and neck cancer when previous treatment has not worked. LN-145 is also called “tumor infiltrating lymphocytes” (TIL) and is made up of specialized white blood cells called lymphocytes or “T cells” grown from your tumor. LN-145 is generated by sending a piece of your own tumor(s) to a central manufacturing facility (or lab) to isolate and grow your body’s own T cells in order to give them back to you to help fight your tumor. These T cells were made by your body to attack your tumor. LN-145 is an investigational product. “Investigational” means that is has not been approved by the Food and Drug Administration (FDA), or any other health authority. LN-145 is an autologous cellular therapy, meaning that these T cells are from your own body and not from another person. We are testing LN-145 to see what effect it has on people with metastatic and/or recurrent head and neck cancer. We don’t know if this study will help you. Your condition may get better but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for metastatic and/or recurrent head and neck cancer in the future.
TIL (LN-145) followed by IL-2 with Recurrent and/or Metastatic Squamous Cell
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