Iovance Biotherapeutics, Inc. is carrying out this study to find out if an Investigational Product, called LN-144 (the study drug) is safe and beneficial in the treatment of patients with metastatic melanoma. LN-144 is also called “tumor infiltrating lymphocytes” and is made up of specialized white blood cells called lymphocytes or “T cells” derived from your tumor. LN-144 is generated by bringing your own tumor into a manufacturing facility to isolate and grow T cells that may attack your tumor when LN144 is reinfused back into your body. LN-144 is an investigational drug. “Investigational” means that it has not been approved by the Food and Drug Administration (FDA), or any other health authority. LN-144 is an autologous cellular therapy, meaning the T cells are derived from your own tumor. Approximately 60 male and female patients aged over 18 with metastatic melanoma will complete treatment on this clinical research study. Completing treatment means you have been successfully infused with LN-144 followed by Interleukin-2, “IL-2” (a protein that helps white blood cells regulate their immune response). Prior to LN-144 infusion, you will complete chemotherapy infusion that prepares your body to receive the LN-144 in a way that allows the T cells the best opportunity to attack your tumor.
Autologous Tumor Infiltrating Lymphocytes (LN-144) followed by IL-2 in Metastatic Melanoma
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