Press Releases

The effectiveness of CAR T-cell therapy has been seen maximally in blood cancers- specifically Acute Lymphoblastic Leukemia, Non-Hodgkin Lymphoma, and Multiple Myeloma. In India, investigators from the Indian Institute of Technology Bombay (IIT-B) & Tata Memorial Center, Mumbai worked jointly since 2015 to develop CAR T-cell therapy. They have successfully developed CD19-directed CAR T-cell therapy which is effective against a type of blood cancer called B Acute Lymphoblastic Leukemia (B- ALL), and B- Non-Hodgkin Lymphoma (B-NHL). The therapy underwent extensive testing in pre-clinical models and then was successfully manufactured in clinical-grade manufacturing facilities.

With these efforts, they were able to get the approval of all relevant Committees and finally Drug Controller General of India (DCGI) approval for this therapy in March 2021 for conducting Phase 1 clinical trial at TMC on children and adolescents with B-ALL Adults with B-NHL. Patients included in these trials were those whose disease had relapsed and were not responding to any other known treatment. The Phase 1 trials are over and the therapy has been found to be safe and effective matching results of the best international studies and data. This therapy was thus successfully designed, developed and brought to trial entirely in India with the help of large academic grants from Government agencies.

On the basis of this, Phase 2 trials have been approved for both children and adults with B- ALL or B- NHL. These trials are conducted at Tata Memorial Center and a few other hospitals.

The Department of Biotechnology supports research projects on CAR-T cell therapy for cancers such as B-cell Acute Lymphocytic Leukemia, Multiple Myeloma, Glioblastoma and Hepatocellular Carcinomas. Besides research projects, the Department has recommended the establishment of Virtual Network Centres (VNCs) for the Development of Genetically Engineered 'Off-the-shelf’ and Inducible CAR-T Cells for Cancer Therapeutics, Network Centre

for Research on Glioblastoma Stem cell–targeted T-Cell Immunotherapy using Non-Genetically Engineered Mesenchymal Stromal Cells, and Interdisciplinary Cancer Immunotherapy Network (CIN) for the Design and Development of Novel, Indigenous, Affordable Cell Therapy/Cell-Based Medicinal Products (CTMPs/CBMPs) as Immunotherapeutic Drugs for Cancers in India.

Biotechnology Industry Research Assistance Council (BIRAC), an industry-academia interface agency of the Department of Biotechnology (DBT), Government of India, has supported the following projects under its different schemes:

Sl. No.	Title of the Project	Scheme
1	Chimeric Antigen Receptor CAR T-Cells technology for cancer treatment: Development of a pre-clinical grade manufacturing process as per Industry standards	PACE (Promoting Academic Research Conversion to Enterprise)
2	Evaluation of Safety and Efficacy of CD19 CAR-T Cell Therapy IMN-003A in B Cell Malignancies	BIPP (Biotechnology Industry Partnership Programme)
3	Indigenous Autologous anti-CD19 CAR T-Cell therapy for CD-19 positive Acute Lymphoblast Leukemia ALL and B-Cell Lymphomas	NBM (National Biopharma Mission)
4	First-In-Human Clinical Trial using an indigenously developed CD-19-targeted CAR T-Cells	NBM (National Biopharma Mission)
5	First-in-India GMP-grade plasmid and viral vector manufacturing for CAR-T and other gene therapies	NBM (National Biopharma Mission)