In a first for India, Chimeric Antigen Receptor T-cell (CAR-T) therapy, a type of gene therapy for blood cancer treatment, was successfully conducted last Friday at the Bone Marrow Transplant unit at the Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Hostpital in Mumbai in collaboration with IIT Bombay. The Central government has now allocated Rs 19.15 crore to conduct first-in-human phase-I/ II clinical trials of the CAR-T cells, the Department of Biotechnology (DBT), part of the Ministry of Science and Technology, said on Thursday. The CAR-T therapy has emerged as a breakthrough in cancer treatment, and clinical trials across the globe have shown promising results in end-stage patients, particularly the ones suffering from acute lymphocytic leukemia.

Despite a proven therapeutic potential for cancer patients, this gene therapy is still not available in India. A patient’s CAR-T cell therapy costs Rs. 3-4 crore and, therefore, the challenge lies in not just developing the technology at scale but also bring the cost down. And last Friday’s success may just be the first step in that direction. The CAR-T cells were designed and manufactured at IIT Bombay’s Bioscience and Bioengineering (BSBE) department.

Subhasis Chaudhuri, the director of IIT Bombay, said: “Our scientists along with Tata Memorial Hospital have come out with the most sophisticated therapy in cancer treatment. If the trials are successful, it may save millions of lives by making the treatment available in India at an affordable cost.”

The clinical trials for the “first in India” gene therapy are being conducted by Dr. (Surg Cdr) Gaurav Narula, Professor of Paediatric Oncology and Health Sciences, and his team from TMC, Mumbai. The novel CAR-T cells that will act as drugs were manufactured by Professor Rahul Purwar, Bioscience and Bioengineering (BSBE) department, and his team at IIT Bombay. The design, development, and extensive pre-clinical testing were carried out by IIT-B as a collaborative project with Tata Memorial Center, Mumbai by the two investigators, DBT said via a press release.

The work is partly supported by Biotechnology Industry Research Assistance Council (BIRAC). The National Biopharma Mission, under DBT-BIRAC, is also supporting the TMC-IIT Bombay in the Phase I/II trial of their CAR-T product.

Besides this, the National Biopharma Mission is also supporting the development of a Lentiviral vector manufacturing facility for packaging plasmids used to transfer the modified T cell inside the body, a cGMP facility for T-cell transduction, and the expansion for CAR T-cell manufacturing to two other organisations.