The Sant Pau hospital has developed a new CAR-T immunotherapy drug against B lymphomas. Within the framework of a clinical trial, the therapy has begun to be administered to patients who have not responded to other treatments.
This is the second advanced therapy drug produced and developed entirely by the Center’s Research Institute. It is characterized by the fact that it has been enriched in longer-lasting memory T lymphocytes, with the aim of gaining efficacy against diseases such as diffuse large B-cell lymphoma, follicular lymphoma or mantle cell lymphoma.
Lymphoma is the most frequent blood cancer in Spain, with a forecast of 10,000 new cases of non-Hodgkin lymphoma in 2023, according to estimates by the Spanish Society of Medical Oncology. The disease begins in the cells of the lymphatic system, which help to form and activate the body’s defenses.
Most patients manage to recover through intensive courses of chemotherapy and, frequently, a bone marrow transplant. But relapses are common and, when they do occur, there are very few therapeutic alternatives.
In fact, in Spain there is no authorized and marketed CAR-T drug for follicular or mantle cell lymphoma in patients refractory to at least two or three conventional treatments.
Ten patients will participate in the phase 1 trial of Sant Pau’s new therapeutic proposal and another 30 will join phase 2. The Virgen del RocÃo hospital in Seville collaborates in the project by recruiting patients and co-producing and applying the treatment. The project has received 2 million euros from the “la Caixa†Foundation and has the collaboration of the Josep Carreras Leukemia Institute, the Carlos III Health Institute and the Banc de Sang i Teixits de Catalunya.
The project is based on the selection of a scarce but extremely effective type of lymphocytes (T). “We select these memory T lymphocytes from the same patient and train them so that every time they detect a tumor cell, they eliminate it,†explains Javier Briones, director of the Sant Pau Cellular Immunotherapy and Gene Therapy research group.
“Thus, in a lasting way, in the body of the patient there would be a ‘detector and eliminator’ of any lymphoma cells that reappeared. In short, it is the genetic modification of the T lymphocytes of the same patient so that they attack cancer cellsâ€, says the doctor.
The development of CAR-T immunotherapy projects requires first class facilities and highly qualified and specialized professionals. Thirty hospitals in Spain are part of the network of CAR-T advanced therapy centers against serious diseases such as cancer.
Sant Pau began in 2020 the first trial with a CAR-T immunotherapy drug, a pioneer in Europe, for the treatment of classical Hodgkin lymphoma and refractory non-Hidgkin T lymphoma. The product is in phase 2. In the previous stage of the clinical trial, it was shown that CAR30 memory T cells “have an excellent safety profile, that is, they have very little toxicity, in addition to achieving high efficacy,” according to Hospital. The lymphoma disappeared in 50% of the treated patients.
In February 2021, the Spanish Agency for Medicines and Health Products (AEMPS) authorized the use of CAR-T ARI-0001, produced by the Hospital ClÃnic de Barcelona, ​​as non-industrially manufactured advanced therapy drugs. This is the first CAR-T developed entirely in Europe approved by a regulatory agency, aimed at patients over 25 years of age with lymphoblastic leukemia resistant to conventional treatments.
