India’s own CAR-T cell therapy
- The Central Drugs Standard Control Organisation (CDSCO) this month granted market authorisation for NexCAR19, India’s first indigenously-developed CAR-T cell therapy to ImmunoACT, a company incubated by IIT Bombay.
- This paves the way for the commercial launch of this therapy in India, where it is expected to be available to cancer patients at a tenth of the cost abroad.
What is CAR-T cell therapy, and how do CAR-T cells find and destroy cancer cells?
- CAR-T is a revolutionary therapy that modifies immune cells, specifically T-cells, by turning them into potent cancer fighters known as CAR-T cells.
- T-cells are special cells (white blood cells that find and fight illness and infection) whose primary function is cytotoxic, meaning it can kill other cells.
- In CAR-T therapy, we genetically modify them into cancer-fighting cells.
- These supercharged cells are then put back into the body, and they go after cancer cells especially in blood cancers like leukaemia and lymphomas.
How effective and different is this from other cancer treatments like, say, chemotherapy?
- 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’s a lifeline for non-responsive cancer patients.
Is NexCAR19 a type of CAR-T therapy?
- 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.
- Even some developed nations don’t have their own CAR-T therapies; they import them from the United States or Europe.
- India is now one of the first developing countries to have its indigenous CAR-T and gene therapy platform.
Who can get the NexCAR19 therapy?
- The therapy is for people with B-cell lymphomas who didn’t respond to standard treatments like chemotherapy, leading to relapse or recurrence of the cancer.
- The patient’s journey starts with a doctor’s prescription at the clinic, followed by donation of blood by the patient at a transfusion centre.
- The blood goes to the lab, where the T-cells are genetically modified.
- In a week to 10 days, these cells return to the clinic for patient reinfusion.
- Essentially, patients only need to give a blood sample at their clinic, and come back in 7-10 days for reinfusion.
- Recovery typically occurs within two weeks after one cycle of the treatment.
- According to the 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.
- B-cell leukaemia is most common among children.
Do children eligible for the therapy too?
- The paediatric trial phase is currently underway at the Tata Memorial Hospital, in collaboration with IIT-Bombay.
- Although the therapy for children will not be any different, for now, ImmunoACT has received CDSCO approval for use in patients aged 15 years and older.
Is India’s indigenous CAR-T cell therapy any more or less effective than CAR-T cell therapies abroad?
- Laboratory and animal studies have shown a unique quality of this product.
- Specifically, it leads to significantly lower drug-related toxicities.
- It causes minimal damage to neurons and the central nervous system, a condition known as neurotoxicity.
- Neurotoxicity can sometimes occur when CAR-T cells recognise the CD19 protein and enter the brain, potentially leading to life-threatening situations.
- The therapy also results in minimal Cytokine Release Syndrome (CRS), which is characterised by inflammation and hyperinflammation in the body due to the death of a significant number of tumour cells, as CAR-T cells are designed to target and eliminate cancer cells.