New Delhi: Researchers from Indian Institute of Technology (IIT) Bombay and Tata Memorial Hospital (TMH), Mumbai have published the clinical trial data of NexCAR19 – India’s first indigenous CAR-T cell therapy.
An affordable cell and gene therapy for cancer treatment, it was approved by the Central Drugs Standard Control Organisation (CDSCO), India’s drug regulator, in October 2023, reported India Today.
What is the therapy
CAR-T cell therapy is a type of immunotherapy for cancer treatment whereby the patient’s immune cells or T cells are modified to kill cancer cells. CAR stands for — chimeric antigen receptor.
T cells are extracted from the cancer patient’s blood, and modified in such a way so as to recognise cancer cells and kill them.
The T cells are then mass-produced and infused back into the patient’s blood so that they can do the needful.
“CAR is the receptor on the T cell’s surface. It has multiple domains. When the modified CAR-T cells come in contact with the cancer cells, the cancer cells express an antigen. We modified CAR-T cells against that antigen. The T cells bind the antigen, give the signal and then kill the cancer cells,” Dr Alka Dwivedi, who was involved in the treatment’s development, told India Today Digital.
“This is India’s first gene therapy for cancer, which offers new hope to patients,” said IIT-Bombay’s Prof. Rahul Purwar, who helped develop the treatment.
CAR T-cells remain in the body for a long time and help prevent cancer from relapsing, explained Dr Hasmukh Jain from Tata Memorial Hospital.
The therapy was tested on patients with B-cell leukaemia and lymphoma, which are rare types of blood cancers that affect the bone marrow and lymphatic system.
The study, published in The Lancet Haematology, has revealed that the injection had a 73% response rate among Indian patients in clinical trials.
How was India’s CAR-T cell therapy was developed
It took 11 years to develop the NexCAR19 treatment through research, lab tests and patient trials.
Clinical trials were conducted in two phases in India. In Phase 1, 14 patients who had a relapse of cancer or treatment-resistant B-cell lymphoma received the therapy.
In Phase 2, 50 patients with B-cell leukaemia or B-cell lymphoma were treated.
Forty-nine men and 15 women, aged around 44 years, participated in the trials.
The results of trial
As many as 73% of patients studied responded well to the treatment. The downside was death of two patients during treatment, while some patients experienced side-effects like low white blood cell count, low platelet count and anaemia.
Despite the few setbacks and challenges, the researchers concluded that the therapy is safe and provides long-term benefits for patients in India.
According to Dr Jain, the next step is to test the therapy in earlier stages of cancer and combine it with other treatments to improve results. New trials have already started at Tata Memorial Centre, Mumbai.
Better affordability
Among major positives of this breakthrough is that not only does it offer hope for thousands of patients in India who earlier had limited treatment options for aggressive blood cancers, the therapy is also comparatively more affordable.
Similar therapies cost around Rs 3-4 crore in countries like the US, with the total cost, including care, likely to exceed $1 million (Rs 8 crore).
On the other hand, the Indian version of the therapy is available for Rs 25 lakh ($30,000), less than one-tenth of the price of other global treatments.
