ImmunoACT gets CDSCO approval for India's first CAR-T cell therapy for blood cancer

NexCAR19 is an indigenously developed CD19 targeted CAR-T cell therapy. It is the first- of-its kind, a Made-in-India product and is a major stride in advanced cell-and-gene therapies

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26 Aug, 2025 12:21

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IIT-B and Laurus Labs backed ImmunoACT announced the approval of India's first CAR-T cell therapy, NexCAR19 (Actalycabtagene autoleucel), for the treatment of r/r B-cell lymphomas and leukemia from the Central Drugs Standard Control Organization (CDSCO).

Immunoadoptive Cell Therapy Private Limited ("ImmunoACT") received the marketing authorization approval for the first humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy product for relapsed/refractory (r/r) B-cell lymphomas and leukemia in India.

NexCAR19 is an indigenously developed CD19-targeted CAR-T cell therapy. It is the first-of-its-kind, made-in-India product and is a major stride in advanced cell-and-gene therapies.

NexCAR19 is the culmination of a collaborative effort across a decade, between the IIT- Bombay, and Tata Memorial Centre (TMC). Dr Atharva Karulkar, Dr Alka Dwivedi and the team led by Dr Rahul Purwar, Associate Professor at IIT Bombay designed and developed the NexCAR19, which subsequently underwent integrative process development & manufacturing under cGMP at ImmunoACT. Clinical investigations and translational studies were led by Dr Hasmukh Jain and Dr Gaurav Narula and their teams at TMH.

Laurus Labs acquires 26.62% stake in ImmunoACT for Rs 46 crore

The clinical trial, led by Dr Hasmukh Jain, was conducted with 60 patients of r/r B-cell lymphomas and leukemia. The clinical data indicates approximately 70 percent overall response rate (ORR). The safety profile in terms of cytokine release syndrome (CRS) and absence of neurotoxicity indicates a significant improvement over the other commercially approved CD19-directed CAR-T cell therapies. "NexCAR19 has shown an excellent balance of efficacy and low toxicity, which is a significant advantage in clinical management (post-infusion) of the patients in our resource-constrained settings," Dr Hasmukh Jain noted.

"Now our patients in India and countries with limited resources will have access to this life-saving drug at an affordable cost. In terms of technical achievement, this is comparable to the moon shot and it puts India on the elite list of select countries that have access to CAR-T therapy," said Dr Rahul Purwar, Founder & CEO of ImmunoACT.

ImmunoACT is an IIT Bombay incubated company under the aegis of SINE (Society for Innovation and Entrepreneurship) and was founded in 2018 with the intention to be able to translate this academic research into a commercially viable product.

Laurus funding will help make CAR-T therapy affordable in India: Rahul Purwar, ImmunoACT

Pharma major Laurus Labs Limited was the early backer of ImmunoACT and has invested over $18 million to support ImmunoACT to scale its R&D and commercialization efforts.

ImmunoACT intends to make the NexCAR19 (Actaly cabtagene autoleucel) therapy available to its partner hospitals as soon as possible.