Pioneering CAR-T therapy in Europe – Dr. Julio Delgado’s academic breakthrough

In the heart of Barcelona, at Hospital Clínic de Barcelona, a quiet revolution in cancer treatment is unfolding. Dr. Julio Delgado, Head of the Oncoimmunotherapy Unit and consultant haematologist, is not only treating patients, he’s reshaping the future of cell therapy in Europe.

Dr. Julio Delgado’s work is a powerful reminder that academic medicine can do more than publish papers, it can change lives. By combining clinical insight with regulatory savvy and a deep commitment to patients, he’s helping to democratize access to some of the most advanced therapies in the world.

Dr. Delgado presented his work and views during the most recent webinar that was organised in the framework of our GET-IN MSCA training program.

From Clinic to Lab: A dual role in innovation

Dr. Delgado wears two hats. On Mondays, he’s a hematologist treating patients. The rest of the week, he’s a drug developer, navigating the complex world of regulatory science and advanced therapy medicinal products (ATMPs). His work bridges the gap between bedside care and cutting-edge research.

His most notable achievement? Leading the development of ARI-0001 (varnimcabtagene autoleucel) — the first fully academic CAR-T cell therapy approved in a EU member state. This milestone not only marks a scientific triumph but also a regulatory one, showing that academic institutions can bring innovative therapies to market.

Why CAR-T?

Dr. Delgado’s journey into CAR-T therapy began with a pivotal 2011 paper on chronic lymphocytic leukemia (CLL) and the support of visionary leadership at his clinic. CAR-T therapies, which engineer a patient’s own immune cells to fight cancer, have since become a cornerstone of modern hematologic oncology.

But for Dr. Delgado, it wasn’t just about following a trend. Developing an in-house CAR-T product meant:

• Direct access for patients in need, especially those not eligible for commercial treatments.

• Flexibility to improve the therapy, such as targeting BCMA when cancer cells escape CD19-directed treatments.

• Affordability, with production costs significantly lower than commercial alternatives.

Navigating the regulatory maze

Unlike traditional academic research, developing a therapy for patient use means thinking like a drug developer. Dr. Delgado emphasized the importance of understanding what regulators require, not just what makes for a good publication.

This mindset, of talking and working with regulators, led to the successful approval of ARI-0001 under the Hospital Exemption pathway, a regulatory route that allows non-commercial therapies to be used under strict conditions. While not widely supported, especially among pharmaceutical companies, this pathway is vital for patients who fall through the cracks of commercial drug access.

A Model for sustainable innovation

By manufacturing vectors in-house and reusing clean rooms, Dr. Delgado’s team has slashed production costs per treatment far below commercial prices. These therapies are offered without profit, underscoring the mission-driven nature of the project.

Catalonia’s unique healthcare ecosystem has supported this model, but the implications are broader. Even in countries like Germany, where commercial CAR-Ts are widely available, academic products remain essential for certain patient populations.

What’s next?

The future is already taking shape. Dr. Delgado’s team is now exploring CAR-T therapies for HER2-positive breast cancer, venturing into the challenging realm of solid tumors. It’s a bold step, but one grounded in the same principles: innovation, accessibility, and patient-centered care.