Chimeric antigen receptor T-cell (CAR-T) therapy has emerged as a breakthrough in cancer treatment. Clinical studies conducted worldwide have shown promising results in end-stage patients, especially those suffering from acute lymphoblastic leukemia. While this technology has remarkable therapeutic potential for cancer patients, it is not currently available in India. Each patient’s CAR-T cell therapy costs Rs 3-4 crore. The challenge is therefore to develop this technology in a cost-effective way and make it available to patients.
The complexity of manufacturing is a major driver of therapy costs. To promote and support the development of CAR-T cell technology against cancer and other diseases, BIRAC and DBT have initiated initiatives and launched specialized calls to invite proposals over the past 2 years.
June 4, 2021 was a historic day for TMH, IIT Bombay team and cancer care in India as the first CAR-T cell therapy (a type of gene therapy) was performed at ACTREC’s bone marrow transplant unit, Tata Memorial Center in Bombay. The CAR-T cells were designed and manufactured at the Department of Bioscience and Bioengineering (BSBE) of IIT Bombay.
This work is supported in part by the BIRAC-PACE scheme. The TMC-IIT Bombay team is further supported to expand this project to conduct Phase I/II trial of their CAR-T product by DBT/BIRAC, through National Biopharma Mission.
This is a “first in India” gene therapy in an early phase clinical trial study 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 19.15 crore for the team to conduct a first-in-human phase-1/2 clinical trial of the CAR-T cells. The clinical trials will be conducted by Dr (Surg Cdr) Gaurav Narula, Professor of Pediatric Oncology and Health Sciences, and his team from TMC, Mumbai, and the new CAR-T cells that will act as drugs manufactured by Prof Rahul Purwar, Department of Bioscience and Bioengineering (BSBE) and his team at IIT Bombay. The design, development and extensive preclinical testing was performed by IIT-B as a collaborative project with Tata Memorial Center, Mumbai by the two researchers.
IIT-B director Subhasis Chaudhuri said this was a significant achievement for both the institute and the country. “We at IIT-B are delighted that our scientists have partnered with Tata Memorial Hospital to present the most advanced therapy in cancer treatment. If the trials are successful, it could save millions of lives by making the treatment available in India at an affordable price. It is an IIT-B investigation that is expected to touch everyone’s lives,” Chaudhuri said.
National Biopharma Mission is also supporting the development of lentiviral vector production facility for packaging plasmids used to transfer the modified T cell into the body, cGMP facility for T cell transduction and expansion for CAR T cell production to two other organizations. The development of CAR-T cell technology for diseases such as acute lymphoblastic leukemia, multiple myeloma, glioblastoma, hepatocellular carcinoma and type 2 diabetes is supported by DBT.
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