Barcelona (EFE).- The Vall d’Hebron Hospital has included the first patient in an international clinical trial that will test the safety and efficacy of applying an advanced cell therapy, known as CAR-T, to lupus patients, which already It is applied successfully in some cases of blood cancers.
Lupus is a chronic disease that mainly affects women and is caused by an attack by the immune system itself: the body produces antibodies that damage the body, with various effects, such as joint problems, kidney problems, skin or heart.
Between 20 and 30% of cases the disease cannot be controlled with conventional medication, aimed at regulating the immune system and reducing inflammation, and it is in these refractory patients that CAR-T could be applied as an alternative. .
Test safety and efficacy in patients with lupus, the goal of therapy
Testing the safety and efficacy of this innovative therapy is the objective of this first international trial, in which Vall d’Hebron has included the first patient -who will begin the process next Monday- of the total of 12 who will participate in the first phases of the study.
To create this group of 12 patients between the ages of 18 and 65 with severe lupus, they are expected to recruit cases from another Spanish hospital, the Gregorio Marañón hospital in Madrid, and centers in France, Germany, Australia and perhaps soon also in the United States, has explained the head of the Lupus Unit in the Rheumatology group of the Vall d’Hebron Research Institute (VHIR), Josefina Cortés.
There is a precedent for success in Germany, where a hospital tested this CAR-T therapy and reported five cases with disease remission late last year, but it was not done in a clinical trial format, so the one starting now It is the first and, furthermore, at an international level, Cortés has assured.
This international phase Ib/IIa clinical trial is promoted by the pharmaceutical company Novartis and, in addition to Vall d’Hebron, has the collaboration of the Blood and Tissue Bank of Catalonia (BST).
A personalized therapy
CAR-T immunotherapy (Chimeric Antigen Receptor T-Cell or T-cell chimeric antigen receptor) is a treatment based on the use of the patient’s own cells to cure the disease, which is already used in blood cancers, such as leukemias or lymphomas, always in cases of patients who do not respond to the first treatments.
It consists of extracting blood from the patient, separating the T lymphocytes (key cells in the immune system) to make the necessary modifications with them in the laboratory so that they recognize and attack cancer cells, and injecting these cells back into the patient.
In the case of lupus, this modification will consist of preparing the T lymphocytes to eliminate the B lymphocytes, responsible for the proliferation of the antibodies that cause lupus, so it is expected that with this approach the outbreaks will stop appearing. the disease, indicated the director of the CAR-T Program of the Vall d’Hebron Hematology Service, Pere Barba.
Although CAR-T therapies are “very promising,” as has already been shown in blood cancers, they are complex procedures that can have side effects.
Low-intensity chemotherapy to prepare the body
Before injecting the new therapy, patients must receive low-intensity chemotherapy to prepare the body to accept these new modified cells.
After applying the treatment, the patient must be hospitalized for between 10 and 14 days to monitor possible side effects and, when he is discharged, he must continue living 30 minutes from the hospital for two more weeks, in case any complications appear, Barba has detailed.
Thus, in the event that this clinical trial gives the expected results and ends up being approved as a therapy for lupus, the specialists point out that, as is the case with blood cancers, it would only be to treat those patients who are not You can control the disease with conventional treatment.
The origin of lupus is still unknown, which has an incidence of 210 patients per 100,000 inhabitants, 90% women, and a large part of them between the ages of 20 and 40.