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Adoptive Immunotherapy using Genetically Modified Lymphocytes for Lymphoproliferative Disorders or Hematological Malignancies

September 7, 2017
Rationale: CAR T cells and genetically engineered TCR T cells are targeted, personalized therapies for malignancies and other neoplastic disorders, including hematological cancers and lymphoproliferative diseases. Although alternative treatments, including chemotherapy, radiation, monoclonal antibodies, hematopoietic stem cell transplants (HSCTs), and adoptive immunotherapy with tumor-infiltrating lymphocytes (TILs), have been used with varying success, all carry the risk of treatment failure, negative off-target effects, and fatal complications. CAR T and TCR T cells are highly tumor-specific and tumor-reactive, personalized, gene transfer-based technologies that may overcome issues surrounding immune tolerance for tumor-specific T cells.
 
Technology Description: CAR T cells and genetically engineered TCR T cells are manufactured by collecting lymphocytes from a patient or healthy donor and modifying them ex vivo through gene transfer techniques. CAR T and TCR T cells are then infused back into a patient’s body, where they direct a targeted immune response to cancerous tissue.
 
Controversy: CAR T cells and TCR T cells are relatively novel technologies with a paucity of clinical efficacy and safety data. Further, for CAR T cells, there are reports of serious complications, including cytokine release syndrome (CRS) and neurologic toxicities, which can lead to death.
 
Key Questions:
  • Are CAR T cell and genetically engineered TCR T cell therapies effective in treating hematologic cancers and lymphoproliferative disorders?
  • How do CAR T and TCR T cell therapies compare with alternative treatments for hematologic cancers and lymphoproliferative disorders?
  • Are CAR T and TCR T cell therapies safe for patients with hematologic cancers and lymphoproliferative disorders?
  • Have definitive patient selection criteria been identified for CAR T and TCR T cell therapies?