MUMBAI: An indigenously developed therapy for treatment of relapsed/refractory B-cell lymphomas and leukaemia by an IIT-Bombay spin-off company has received approval from the national regulatory body and will be available in at least 20 major hospitals in the country, including Tata Memorial Hospital, in the first phase.

With this nod, India joins an elite club of select countries that offer such treatment. Its cost in India will be Rs 30-40 lakh—about 10% of what it costs overseas.
City-based Immunoadoptive Cell Therapy Private Limited (ImmunoACT) received the authorisation approval for the first chimeric antigen receptor T cell (CAR-T cell), called NeXCAR19 (actalycabtagene autoleucel). The therapy will put India on the world map of advanced cell-and-gene therapies, said a statement by ImmunoACT.
Under the therapy, blood is taken from the patient and the T-cells, which help the immune system fight back diseases, are genetically modified or re-engineered by adding lentiviral vectors. These genetically modified cells are then injected back into the patient where they attack and kill cancer cells.

IIT-Bombay professor Rahul Purwar, who is the founder and CEO of the company, said the approval is significant as it is one of the most complex therapies to be fully developed in the country. Purwar said they have signed MoUs with at least 20 government and private hospitals. Apart from Tata Memorial Hospital, Deenanath Mangeshkar Hospital in Pune, Rajiv Gandhi Cancer Hospital and Max Super Speciality Hospital in Delhi, Continental Hospitals in Hyderabad, American Oncology Institute are some of the hospitals to offer the treatment in the first phase.
The multi-centre Phase I/II pivotal clinical trial, led by Dr Hasmukh Jain, was conducted with 60 patients of relapsed/refractory B-cell lymphomas and leukaemia at Tata Memorial Hospital, said Purwar. The data indicated around 70% overall response rate. The safety profile in terms of cytokine release syndrome (an acute systemic inflammatory syndrome) and absence of neurotoxicity indicated a significant improvement over the other commercially approved CD19-directed CAR-T cell therapies.


In a statement, Jain said, “NexCAR19 has shown an excellent balance of efficacy and low-toxicity, which is a significant advantage in clinical management (post-infusion) of the patients in our resource-constrained settings.”

On the clinical trials’ success, Purwar said, “Now, our patients in India and countries with limited resources will have access to this life-saving drug at an affordable cost. In terms of technical achievement, it puts India on the elite list of select nations with access to CAR-T therapy.”