Indigenous CAR-T Therapy Marks Milestone for India's Cancer Care and Biotech Manufacturing

ImmunoACT's CAR-T therapy represents the first domestically developed and manufactured CAR-T therapies to enter the commercial landscape in India. Since its introduction, it has been administered to more than 600 patients with relapsed or refractory B-cell malignancies, according to company disclosures. The therapy was approved by the CDSCO in 2023 for B-cell cancers.

CAR-T therapy—short for chimeric antigen receptor T-cell therapy—is a personalised treatment that involves collecting a patient's own immune T-cells, genetically modifying them to recognise cancer cells, and reinfusing them after laboratory expansion. The therapy is administered at specialised centres equipped to manage potential complications. Globally, CAR-T therapies targeting CD19 have been used in relapsed or refractory B-cell malignancies, including certain types of Acute Lymphoblastic Leukaemia (ALL) and NHL.

Unlike imported CAR-T products that often require overseas cell shipment and cross-border logistics, ImmunoACT became the first Indian Company which manufactures its CAR-T therapy entirely within India. This localised production model reduces dependency on international suppliers and allows tighter coordination across collection, processing, and reinfusion stages. The reported manufacturing turnaround time is approximately 17-20 days. Industry observers note that supply continuity and logistical control are critical variables in cell and gene therapy delivery.

ImmunoACT's CAR-T therapy is used to treat eligible patients whose blood cancers have relapsed or have not responded to previous treatments. Global studies show that CAR-T cell therapies can help patients who have already tried other treatments in previous lines. The therapy also has a US patent protection for a humanised CAR construct—a design element intended to align with immunologic engineering principles seen in next-generation cellular therapies.

Treatment outcomes vary based on disease characteristics, prior therapies, individual response and multiple clinical factors. CAR-T therapy may cause side effects that are severe or life-threatening that require intensive monitoring and supportive care. Treatment must be administered in specialised centres with trained teams and appropriate critical-care facilities.

In India's predominantly self-funded oncology landscape, affordability remains a major determinant of access. Domestic manufacturing has enabled differentiated pricing within the Indian treatment landscape. ImmunoACT has also introduced structured patient-support initiatives, including bridge financing mechanisms and defined value-based pricing models. These initiatives are designed to assist eligible patients navigating the financial demands of advanced therapies.

Health policy experts note that long-term integration of CAR-T in India will likely depend on broader reimbursement evolution, insurance participation, and infrastructure expansion at specialised centres. There are other healthcare companies which are also now exploring this treatment space, but it is yet to see if they can build similar indigenous manufacturing capabilities.