India has made significant strides in developing indigenous CAR T-cell therapy for blood cancers, particularly Acute Lymphoblastic Leukemia, Non-Hodgkin Lymphoma, and Multiple Myeloma. A collaborative effort between the Indian Institute of Technology Bombay (IIT-B) and Tata Memorial Center (TMC), Mumbai, has led to the successful development of CD19-directed CAR T-cell therapy.
Development and Clinical Trials
Since 2015, IIT-B and TMC have been working on this therapy, which targets CD19, a protein found on the surface of certain blood cancer cells. The therapy has shown effectiveness against B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL). After rigorous testing in pre-clinical models and manufacturing in clinical-grade facilities, the therapy received approval from the Drug Controller General of India (DCGI) in March 2021 for Phase 1 clinical trials at TMC.
The Phase 1 trials included children and adolescents with B-ALL and adults with B-NHL whose disease had relapsed or was unresponsive to other treatments. The results indicated that the therapy is safe and effective, aligning with data from leading international studies. These positive outcomes have paved the way for Phase 2 trials, which are currently underway at Tata Memorial Center and other hospitals.
Government Support and Research Initiatives
The Department of Biotechnology (DBT) is actively supporting research projects focused on CAR-T cell therapy for various cancers, including B-cell Acute Lymphocytic Leukemia, Multiple Myeloma, Glioblastoma, and Hepatocellular Carcinomas. DBT has also recommended establishing Virtual Network Centres (VNCs) to advance genetically engineered 'Off-the-shelf' and Inducible CAR-T Cells for Cancer Therapeutics.
These networks aim to foster research on Glioblastoma Stem cell-targeted T-Cell Immunotherapy using Non-Genetically Engineered Mesenchymal Stromal Cells and to create an Interdisciplinary Cancer Immunotherapy Network (CIN) for developing novel, indigenous, affordable cell therapy products as immunotherapeutic drugs for cancers in India.
BIRAC's Role in Advancing CAR T-Cell Technology
The Biotechnology Industry Research Assistance Council (BIRAC), an interface agency of DBT, supports several projects under its schemes to promote CAR T-cell technology. These include:
- Development of a pre-clinical grade manufacturing process for Chimeric Antigen Receptor CAR T-Cells technology for cancer treatment.
- Evaluation of the Safety and Efficacy of CD19 CAR-T Cell Therapy IMN-003A in B Cell Malignancies.
- Development of Indigenous Autologous anti-CD19 CAR T-Cell therapy for CD-19 positive Acute Lymphoblast Leukemia ALL and B-Cell Lymphomas.
- First-In-Human Clinical Trial using an indigenously developed CD-19-targeted CAR T-Cells.
- Establishment of First-in-India GMP-grade plasmid and viral vector manufacturing for CAR-T and other gene therapies.
