The first CAR-T cell therapy for blood cancer in India is approved by the CDSCO

Backed by Laurus Labs and IIT-Bombay, ImmunoACT received approval by the Central Drugs Standard Control Organisation (CDSCO) for the treatment of relapsed/refractory B-cell lymphomas and leukaemia which is called NexCAR19 (Actalycabtagene autoleucel), India's first CAR-T (Chimeric Antigen Receptor T cell therapy. NexCAR19 a CD19-targeted CAR-T cell treatment is a ground-breaking product created in India that represents a significant development in cell and gene therapy. 

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 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. 

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.  

Dr Hasmukh Jain noted, "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".