Context: For decades, oncologists have relied on chemotherapy, radiation and surgery to treat cancer patients. CAR T-cell therapy is among the most promising recent developments, especially because it has shown the ability to eradicate advanced leukemias and lymphomas.
In October 2023, India’s drug regulator Central Drugs Standard Control Organisation approved NexCAR19 as India's first indigenously-developed CAR-T cell therapy.
Now, a 64-year-old has become the first patient in the country to be free of cancer cells after being administered this therapy.
- This paves the way for the commercial launch of the therapy in India, where it is expected to be available to cancer patients at a tenth of the cost abroad.
- For now, ImmunoACT has received CDSCO approval for use in patients aged 15 years and older.
What is CAR-T cell therapy?
- Chimeric antigen receptor (CAR) T-cell therapy is a type of cell-based gene therapy which involves altering the genes inside T-cells to help them attack cancer cells.
- T-cells are special cells (a type of white blood cells that find and fight illness and infection) whose primary function is cytotoxic, meaning it can kill other cells.
- In the therapy, T-cells are harvested from the patient’s blood.
- Researchers modify these cells in the laboratory so that they express specific proteins on their surface known as chimeric antigen receptors (CAR).
- These cells are then grown and multiplied in the laboratory and then inserted back into the patient.
- This genetic modification allows CAR T-cells to effectively bind to the cancer cells and destroy them — especially in blood cancers like leukaemia and lymphomas.
- As CAR-T cells directly activate the patient’s immune system against cancer, it makes the treatment more clinically effective than surgery, Radiotherapy and Chemotherapy.
- India is one of the first developing countries to have its indigenous CAR-T and gene therapy platform.
Advantages over other treatments:
- Precision targeting: CAR-T cells are designed to specifically recognise and attack cancer cells. This specificity reduces damage to healthy cells/tissues, minimising side effects compared to conventional treatments like chemotherapy.
- Long-lasting effect: The therapy directly activates the patient’s immune system against cancer cells, thus potentially providing long-term remission to patients.
- Treatment for refractory cases: CAR-T cell therapy has shown promise in treating patients who have not responded to standard treatments or with cancer relapse.
Concerns:
- Potential side effects are also significant, associated with:
- Cytokine release syndrome (a widespread activation of the immune system and collateral damage to the body’s normal cells).
- Neurological symptoms (severe confusion, seizures, and speech impairment).
- The complexity of preparing CAR T-cells has been a major barrier to their use. Also, the therapy involves considerable cost (about Rs 40 lakh in India) and skilled technical and human resources for its administration.
About NexCAR19:
- NexCar19 is a type of CAR-T and gene therapy developed indigenously in India by ImmunoACT, which is a company incubated at IIT Bombay.
- The therapy is designed to target cancer cells that carry the CD19 protein. This protein acts like a flag on cancer cells, which allows CAR-T cells to recognise and attach themselves to the cancer cells and start the process of elimination.
- The therapy is for people with B-cell lymphomas who did not respond to standard treatments like chemotherapy, leading to relapse or recurrence of the cancer.
- Recovery typically occurs within two weeks after one cycle of the treatment. In our data, approximately 70% of patients respond to the treatment, with variations between leukaemia and lymphoma cases.
- About 50% of these responsive patients achieve a complete response.
CAR-T therapy vs other treatments:
- While chemotherapy and immunotherapy may add a few months or years to a cancer patient’s life, cell-and-gene therapy is designed to cure and provide lifelong benefit.
- It makes treatment easier with a one-time therapy [unlike several sessions of chemotherapy] that can be truly transformative for a patient. It is a lifeline for non-responsive cancer patients.