Miltenyi Biotec’s ZAMTO Cell, claimed to be India's first dual-target CAR-T cancer therapy, expected by 2026

German biotechnology company Miltenyi Biotec has said that its CAR-T therapy, ZAMTO Cell, for B-cell lymphoma, is expected to be available in India by early 2026. CAR-T (Chimeric Antigen Receptor T-cell) therapy is a form of immunotherapy in which a patient’s own T cells are genetically modified to recognise and attack cancer cells.
 
The company has applied for Phase 2 trials with the drug regulator and is working with Christian Medical College (CMC) Vellore to advance clinical development. If approved, ZAMTO Cell would be the first dual-target CAR-T therapy in India, potentially expanding treatment options for blood cancer patients.
 
While CAR-T therapies developed by global pharmaceutical companies such as Novartis (Kymriah), Gilead (Yescarta), and Johnson & Johnson (Carvykti) have shown significant success in treating certain blood cancers, access to these treatments in India has been limited due to the high cost. The treatment can exceed ₹3-4 crore per patient, making it affordable only for a small number of individuals who can seek treatment abroad.
 
Miltenyi Biotec has said that it aims to make CAR-T therapy more accessible in India. “Phase 1 involved testing on nine or ten patients at CMC Vellore, which has now been completed. For Phase 2, we are hopeful for quick approval. If everything proceeds smoothly, we should hear about Phase 2 by the second quarter,” said Priya Hingorani, Managing Director of Miltenyi Biotec India.
 
The company said that ZAMTO Cell is designed to target both CD19 and CD20, which could improve treatment efficacy. Dual-targeting has been shown in studies to reduce relapse rates, which remains a key challenge with single-target CAR-T therapies. India records over 50,000 new cases of blood cancers annually, and existing treatment options, including chemotherapy and bone marrow transplants, come with limitations in terms of effectiveness and availability.
 
“India has a much larger patient base than Europe and North America due to its population size. Historically, this has been a key factor. Our goal is to ensure this technology is widely accessible and not limited to a select few,” said Dr. Boris Stoffel, Chief Commercial Officer and Member of the Board at Miltenyi Biotec B.V. & Co. KG.
 
In India, domestic efforts to develop CAR-T therapies have been underway. IIT Bombay’s ImmunoACT became the first company to receive regulatory approval for a CAR-T therapy in India, with NexCAR19 approved in 2023. However, large-scale manufacturing and distribution of CAR-T therapies remain a challenge in the country.
 
Miltenyi Biotec has said that it is also focusing on training and infrastructure to support the introduction of CAR-T therapy in India. The company’s Hyderabad-based Miltenyi Innovation and Technology Center (MITC) plays a role in training hospital staff and researchers to ensure effective deployment of the treatment. “We assist by running the machines initially, but we also provide training. Our focus is on equipping hospital staff with the necessary skills, which will allow us to expand our work to more centres,” Hingorani said.
 
The cost of CAR-T therapy remains a key concern in India. Miltenyi Biotec has not disclosed the expected pricing for ZAMTO Cell but has said that it is exploring partnerships to reduce costs. “Right now, CAR-T therapy may seem expensive, but as technology advances—just like with MRI and CT scans—accessibility and affordability will improve,” Hingorani said.
 
Beyond B-cell lymphoma, the company is also evaluating the use of CAR-T therapy for other conditions, including thalassaemia and sickle cell disease. “Many patients are waiting for this treatment. Our priority is saving lives,” Hingorani added. As CAR-T therapy gains traction in India, competition in the sector is expected to increase. “This mirrors developments in Japan and the US, where multiple institutions are now working on CAR-T therapies targeting not just B-cell lymphoma but also multiple myeloma and solid tumours,” Hingorani said.