NexCAR19: CDSCO approves India’s first CAR-T cell therapy

IIT Bombay-incubated company Immunoadoptive Cell Therapy (ImmunoACT) has received Central Drugs Standard Control Organisation’s (CDSO) marketing authorisation approval of the first humanised CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy product NexCAR19 for relapsed/refractory B-cell lymphomas and leukaemia in India.

About NexCAR19

  • NexCAR19 is an indigenously developed CD19-targeted CAR-T cell therapy. It is the first-of-its-kind, made-in-India product and is a major stride in advanced cell-and-gene therapies.
  • The development will offer hope to thousands of blood cancer and lymphoma (cancers of the lymph system) patients in the country who cannot afford to travel abroad to avail the cutting-edge therapy, an advanced form of immunotherapy first launched in the US in 2017.

About CAR T-cell therapy

  • T cells—which help orchestrate the immune response and directly kill cells infected by pathogens—are the backbone of CAR T-cell therapy.
  • T cells are white blood cells that find and fight illness and infection throughout the body. Each T cell has a receptor that can recognize antigens. When the immune system recognizes foreign or abnormal antigens, it can work to destroy them.
  • But cancer cells sometimes have antigens that body doesn’t recognize as abnormal. As a result, the immune system may not send T cells to fight cancer cells. In other cases, the T cells may not be able to clear the cancer cells.
  • Chimeric antigen receptor T cells are cells that are genetically engineered (changed) in a laboratory. They have a new receptor so they can bind to cancer cells and kill them.
  • Currently available CAR T-cell therapies are customized for each individual patient.
  • They are made by collecting T cells from the patient and re-engineering them in the laboratory to produce proteins on their surface called chimeric antigen receptors, or CARs.
  • After the revamped T cells are “expanded” into the millions in the laboratory, they’re then infused back into the patient. If all goes as planned, the CAR T cells will continue to multiply in the patient’s body and, with guidance from their engineered receptor, recognize and kill any cancer cells that harbor the target antigen on their surfaces.
  • These receptors are “synthetic molecules, they don’t exist naturally.

B cells and T cells

  • A lymphocyte is a type of white blood cell that is part of the immune system. There are two main types of lymphocytes: B cells and T cells.
  • The B cells produce antibodies that are used to attack invading bacteria, viruses, and toxins.
  • The T cells destroy the body’s own cells that have themselves been taken over by viruses or become cancerous.
  • B-cells protect you from infection by making proteins called antibodies. B-cells are a type of white blood cell called lymphocytes. When your immune system detects antigens — markers that indicate a threat like a bacteria or virus has entered your body — your B-cells produce antibodies to fight the invader.

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