New Delhi, Jun 8 (PTI) The Centre has approved Rs 19.15 crore for conducting a first-in-human phase-1/2 clinical trial of the CAR-T cells, a type of gene therapy, for cancer treatment, the Department of Biotechnology (DBT) said on Tuesday.
On June 4, the country's first CAR-T cell therapy was done at the Bone Marrow Transplant unit at ACTREC, Tata Memorial Centre in Mumbai, it added.
The Chimeric Antigen Receptor T-cell (CAR-T) therapy has emerged as a breakthrough in cancer treatment. Clinical trials conducted globally have shown promising results in end-stage patients, especially in patients suffering from acute lymphocytic leukemia.
Though this technology has a remarkable therapeutic potential for cancer patients, at present, it is not available in India. Each patient's CAR-T cell therapy costs Rs 3-4 crore.
The challenge therefore is to develop this technology in a cost-effective manner and make it available for the patients.
The manufacturing complexity is a major reason for the therapy cost. In order to promote and support the development of CAR-T cell technology against cancer and other diseases, the Biotechnology Industry Research Assistance Council (BIRAC) and the DBT have taken initiatives and launched specialised calls to invite proposals in the last two years.
On June 4, the country's first CAR-T cell therapy was done at the Bone Marrow Transplant unit at ACTREC, Tata Memorial Centre in Mumbai. The CAR-T cells were designed and manufactured at the Bioscience and Bioengineering (BSBE) department of IIT, Bombay.
This work is partly supported by the BIRAC-PACE scheme. The TMC-IIT Bombay team is further supported to extend this project for conducting Phase I/II trial of their CAR-T product by DBT-BIRAC through the National Biopharma Mission.
'This is a first in India gene therapy in early phase pilot clinical trial and the dedicated efforts and excellent collaboration between IIT Bombay and Tata Memorial Hospital, Mumbai. The central government's National Biopharma Mission-BIRAC has approved Rs 19.15 crore to the team for conducting a first-in-human phase-1/2 clinical trial of the CAR-T cells,' a statement issued by the DBT said.
The clinical trials are being done by Dr Gaurav Narula, professor of paediatric oncology and health sciences, and his team from TMC, Mumbai, and the novel CAR-T cells that will act as drugs were manufactured by Professor Rahul Purwar, 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 the Tata Memorial Centre, Mumbai.
IIT-B director Subhasis Chaudhuri said this was a significant feat for the institute as well as the country.
'We at IIT-B are delighted that 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. It is a research of IIT-B that is expected to touch the lives of all,' he said.
The National Biopharma Mission is also supporting the development of a lentiviral vector manufacturing facility for packaging plasmids used to transfer the modified T cells inside the body, a cGMP facility for T-cell transduction and expansion for CAR T-cell manufacturing to two other organisations.
The development of the CAR-T cell technology for diseases including acute lymphocytic leukemia, multiple myeloma, glioblastoma, hepatocellular carcinoma and type-2 diabetes is supported through DBT, the statement said. PTI PR RC