The Spanish Agency for Medicines and Health Products (Aemps) has approved CAR-T ARI-0002h, developed by the Clínic-Idibaps hospital, as an advanced therapy medicine of non-industrial manufacture in patients with multiple myeloma resistant to conventional treatments .
This pathology is a cancer of plasma cells, which are found in the bone marrow and are an important component of the immune system. The therapy consists of extracting immune cells from the patient’s blood and modifying the T lymphocytes in the laboratory so that they recognize and have the ability to attack a protein on the tumor cells. Subsequently, they are transfused to the patient. It is a type of cell and gene therapy in which the patient becomes their own donor.
Two multicenter studies in which 60 patients from seven Spanish hospitals participated indicate that 95% showed a response to treatment, with a favorable toxicity profile. “CAR-T therapy is a paradigmatic example of how excellent biomedical research improves the quality of life of people, in this case of patients with multiple myeloma,” said Dr. Elias Campo.
“It is a milestone and is the result of the efforts of many hospital professionals and researchers.”
The approval from the Aemps, presented this morning in Barcelona, is the previous step to the notification of the hospital exemption that the Clínic will receive in the coming days. “It is a milestone and is the result of the efforts of many professionals and researchers at the hospital,” celebrated the center’s general director, Josep Maria Campistol.
Campistol recalled that it is the second CAR-T therapy developed at the Clínic within the framework of the ARI project and the first CAR-T in Europe for multiple myeloma. The first (ARI-0001), aimed at patients with acute lymphoblastic leukemia, was approved by the Aemps in February 2021.
Minister Manel Balcells, among the promoters of the therapy
The difference between the new CAR-T and the previous ones, in addition to the therapeutic target – in this case, the BCMA antigen – is that this time it is humanized. “Mouse antibodies are often used for the development of CAR-T and in this case we have humanized it so that it has greater durability in the patient and a lower probability of rejection,” explained Manuel Juan, head of the immunology service at the Clínic. .
Multiple myeloma, which represents 10% of blood cancers, affects the plasma cells of the bone marrow. Although there are various treatments available, many patients develop resistance, which causes relapses and the need for new therapies such as this CAR-T (genetic modification of the patient’s T cells so that they can recognize and attack cancer cells).
The CAR-T can be built in Barcelona and at the University of Navarra Clinic
In the case of ARI-0002h, the first dose is administered divided into three aliquots. After one hundred days, a booster infusion is administered, which provides a sustained response with low toxicity. “Knowing which patients will respond favorably to the therapy will allow us to optimize the results, adjust the therapeutic strategy and minimize side effects,” said Carlos Fernández de Larrea, a hematologist at the Clínic who has led the development of the procedure.
It is the second CAR-T developed by the Clínic, the first in Europe for multiple myeloma
The development of CAR-T at the Clínic has the fundamental support of the La Caixa Foundation, thanks to a strategic alliance to promote pioneering and high-impact research against cancer and the improvement of care for cancer patients. To carry out the clinical study, specific funding has also been received from the Carlos III Health Institute (ISCIII) and the Bosch Aymerich Foundation.
“What we are doing here today is exceptional,” said the Health Minister, Manel Balcells, at the presentation of the Clínic’s new therapy. “It is the result of teamwork by many very talented people, which is added to other initiatives that also coexist in Catalonia. All this sum means that we can be a reference to improve the quality of life of people who suffer from various diseases such as leukemia, lymphoma or myeloma.”
For Balcells, the challenge now is to socialize new therapies through regulations and collaboration between public and private initiatives. According to the minister, Catalonia is in a position to lead this debate at the European level and, in this sense, he has highlighted the creation of the Català Center for Advanced Teràpies, which “is underway, is approved by the Government, has its budget and before At the end of this month, its board of directors will hold its first meeting.”
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