A multicenter study led by the Hospital Clínic de Barcelona-IDIBAPS has demonstrated the efficacy of the CAR-T ARI0002h immunological therapy to treat patients with multiple myeloma resistant to standard treatments.
The study, published in The Lancet Oncology, shows that all patients treated with this CAR-T, developed in the hospital, show a response to treatment, of which about 70% are complete after 18 months and the rest are partial.
As explained by the Hospital Clínic in a statement, the coordinator of the study was Dr. Carlos Fernández de Larrea, hematologist at the Clínic and head of the IDIBAPS group on myeloma, amyloidosis, macroglobulinemia and other gammopathies.
The development of the CAR-T at the Clínic has the fundamental support of the La Caixa Foundation, thanks to a strategic alliance to promote pioneering research with great impact 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.
The study was carried out in collaboration with the Clínica Universidad de Navarra, which has collaborated with the Clínic to be able to produce this type of therapy, and three other Spanish hospitals: the University Hospital of Salamanca, Hospital Virgen de la Arrixaca in Murcia and the Virgen del Rocío Hospital in Seville.
The researchers predict that it will be a promising option in the treatment of resistant multiple myeloma. It is a type of cell and gene therapy in which the patient becomes their own donor. It consists of modifying the patient's T lymphocytes so that they have the capacity to attack tumor cells.
This is the second CAR-T developed at the Clínic-IDIBAPS. “The difference with respect to the previous CAR-T, in addition to the therapeutic target, which in this case is 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 a greater durability in the patient and a lower probability of rejection”, explains Dr. Manel Juan, head of the Immunology Service of the Clinic
To evaluate the efficacy of the CAR-T ARI0002h, the Clínic-IDIBAPS began a trial with four other hospitals to treat 30 patients with myeloma who had relapsed after two or three previous treatments.
Although the results are promising, patients treated with the ARI0002h continue to relapse, requiring strategies to overcome this obstacle. “We have carried out studies that reveal that there are different mechanisms that could be responsible for relapse after treatment with this CAR-T. On the other hand, we have detected a residence time of CAR-T cells of five months in the blood and, although this time is similar to that of other CAR-T cells for this disease, it is still short”, says Dr. Fernández de Larrea. "Thus, our research is aimed at finding out how we can lengthen the persistence of the CAR-T", he concludes.
Now, the Spanish Agency for Medicines and Health Products (AEMPS) is evaluating the documentation based on the results of this study for its approval as a non-industrially manufactured advanced therapy drug.
