Definition

A preparation of autologous, personalized, immunogenic and tumor neoantigen-specific T lymphocytes, with potential immunostimulating and antineoplastic activities. Tumor-specific neoantigen targets of autologous CD4+ and/or CD8+ T cells are identified and T cells that target immunogenic and stimulatory neoantigens are expanded ex vivo. Upon administration, the autologous neoantigen-specific T lymphocytes GEN-011 recognize and bind to tumor cells expressing the targeted neoantigens, resulting in a cytotoxic T-lymphocyte (CTL)-mediated immune response against the patient’s tumor cells.