Immunology in Clinical Research and Clinical Trial

Immunotherapy is used to fight off diseases such as cancer by stimulating or boosting the patient’s own immune system or giving man-made immune system proteins to attack cancer cells. Some types of cancers respond well to immunotherapy treatment alone while other cancers respond better when used in combination with other types of treatment such as chemotherapy.

Types of cancer immunotherapy or immunology include:

  • Monoclonal antibodies (mAb) are engineered proteins that target tumor-associated antigens which in turn evokes an immune response to kill cancer cells
  • Checkpoint inhibitor therapy targets immune ‘checkpoints’, key regulators of the immune system which cancer cells use to their advantage to protect themselves from immune system attacks. Cancer cells can often escape detection by interfering with these checkpoints on immune cells, notably T-cells. This type of therapy, usually antibody-based, essentially takes the ‘brakes’ off of the immune system and restores immune function by recognizing and destroying cancer cells. There are several checkpoint targets including PD-1 and CTLA-4 which are found on T-cells and PD-L1 found on cancer cells.
  • Cytokines such as interferon interferes with the way cancer cells grow and multiply, stimulates the immune system, and encourages cancer cells to produce chemicals that evoke an immune response
  • Vaccine therapy activates and stimulates the immune system to make antibodies to recognize and fight the disease
  • Adoptive cell transfer such as chimeric antigen receptor (CAR-T) cell therapy in which the patient’s T-cells are extracted, genetically modified, and transferred back into the patient with the aim that these altered cells can now recognize and attack cancer cells

 

  • The safety and effectiveness of new medications and new medical devices depends on clinical research to provide the Food and Drug Administration (FDA) with enough information to decide to approve or reject these products. Human testing, also known as a c

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