Prime Minister Narendra Modi unveiled India's first indigenous CAR-T cell therapy, NexCAR19, during the Emerging Science, Technology and Innovation Conclave (ESTIC) 2025, marking a historic milestone in the country's biotechnology and cancer care landscape. Developed by ImmunoACT, an IIT Bombay spin-off, with support from the Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC), NexCAR19 represents the world's first humanized CAR-T therapy developed in India.
Breakthrough in Cancer Immunotherapy
CAR-T cell therapy, a cutting-edge form of immunotherapy, reprograms a patient's own immune cells to fight cancer and has shown remarkable success in treating blood cancers such as Acute Lymphocytic Leukemia (ALL), particularly in patients with limited treatment options. According to the Ministry of Science and Technology, global clinical trials have demonstrated promising results in end-stage patients, especially those suffering from Acute Lymphocytic Leukaemia.
NexCAR19 stands out as India's first "living drug," designed to make gene therapies affordable and accessible while maintaining global standards of safety and scientific rigor. The therapy addresses the critical need for cost-effective cancer treatment solutions without compromising patient safety or therapeutic efficacy.
Clinical Development and Trials
In 2021, DBT and BIRAC partially supported the Tata Memorial Centre (TMC) and IIT Bombay team for lentivirus manufacturing and clinical trials of India's first CAR-T therapy at the ACTREC centre. The NEXCAR-19 trial in pediatric patients is currently ongoing at Tata Memorial Centre, with ImmunoACT serving as the manufacturing partner.
Clinical trials conducted at the Tata Memorial Centre have shown promising results, underscoring the therapy's potential to transform cancer treatment in India. These trials focus specifically on pediatric patients with leukemia, representing a critical patient population with significant unmet medical needs.
Manufacturing and Scale-Up Capabilities
Under DBT's Biomanufacturing initiative within the BioE3 Policy, funding was recently provided to ImmunoACT to establish a 200L GMP lentiviral vector and plasmid production platform. This advanced manufacturing capability will enable large-scale, high-quality production using advanced bioreactor technologies, with the capacity to manufacture gene delivery vectors for up to 1,000 patients annually.
ImmunoACT emerged from the Society for Innovation and Entrepreneurship (SINE), IIT Bombay's technology business incubator, and received early-stage support under BIRAC's BioNest initiative, including funding, mentorship, and access to advanced research infrastructure.
Broader Cancer Treatment Applications
DBT is actively promoting both early and late-stage translational research in CAR-T and other immunotherapies to develop novel and indigenous CAR-T-based therapeutics for various cancers. The initiative supports interdisciplinary teams venturing into immunotherapeutic solutions for a broader spectrum of cancers, including both liquid and solid cancers, while addressing ways to overcome associated toxicities.
The research scope encompasses multiple cancer types, including multiple myeloma, refractory or relapsed B-cell acute lymphoblastic leukemia, and glioblastoma, demonstrating the platform's potential for treating diverse oncological conditions.
Strategic Impact on Healthcare Innovation
With NexCAR19, India joins a select group of nations developing advanced cell and gene therapies, demonstrating the country's growing capacity to deliver cutting-edge, affordable cancer care. This development represents a significant step toward biotech innovation and self-reliance in critical healthcare technologies, paving the way for a new era in India's biotechnology sector.
