Definition

A preparation of autologous peripheral blood lymphocytes (PBLs) that have been genetically modified to express T-cell receptors (TCRs) specific for K-RAS (KRAS) mutations, with potential immunomodulating and antineoplastic activities. Upon isolation, transduction, expansion ex vivo and re-introduction into the patient, the autologous KRAS mutant-specific TCRs gene engineered PBLs target and bind to KRAS mutants-expressing tumor cells, resulting in a cytotoxic T-lymphocyte (CTL)-mediated killing of KRAS mutants-expressing tumor cells. KRAS, a member of the RAS family of oncogenes, serves an important role in cell signaling, division and differentiation. Mutations of KRAS may induce constitutive signal transduction leading to tumor cell proliferation, invasion, and metastasis.