Lupus is a chronic autoimmune disease caused by an attack by the immune system itself that can damage any organ in the body. Most patients suffer from fatigue and weight loss, among other symptoms, and other manifestations often appear, such as joint pain, skin eruptions, hematological complications or renal involvement.
Currently, there are drugs to regulate the immune system and reduce inflammation, but this drug requires chronic intake and, moreover, in some cases it is not effective.
Now Vall d’Hebron Hospital has enrolled the first patient in a pioneering study that will test the safety and effect of CAR-T immunotherapy in people with lupus. CAR-T therapy is an innovative treatment that, until now, has been developed to treat some types of tumors or hematological diseases, such as lymphomas or leukemias.
CAR-T therapy is a treatment that has been developed to treat some types of tumors or blood disorders.
It is based on extracting cells from the patient’s immune system, in this case T cells, which are genetically modified to express a chimeric antigen receptor (CAR) and then reinfused into the patient. In the case of tumors, this alteration allows the modified cells to attack the tumor cells.
“In lupus, CAR-T cells eliminate the patient’s B lymphocytes responsible for producing the antibodies that cause lupus,” explains Pere Barba, director of the CAR-T Program at the Hematology Service at the Vall d’Universitat Hospital ‘Hebron and researcher in the Experimental Hematology group at the VHIO.
“This therapy restarts the immune system so that it attacks the cells that interest us”, says Mònica Linares, specialist in hematology at the BST.
A pilot study conducted with five lupus patients in Germany showed positive results with CAR-T therapy in late 2022.
We want to verify that, by eliminating the CD19 B lymphocytes, thanks to CAR-T, the symptoms improve and even the antibodies disappear
Josefina Cortes
“In the clinical trial that we are launching now, we want to verify that by eliminating the CD19 B lymphocytes thanks to CAR-T, the symptoms improve and even the antibodies responsible for the disease disappear”, says Josefina Cortés, internist and rheumatologist specialist in Lupus from the Rheumatology Service of the Vall d’Hebron University Hospital and principal investigator of the project.
This is the first multicentric clinical trial that analyzes the safety and effect of therapy in an autoimmune disease and opens doors to the development of new therapies for other pathologies of this type as well.
“If we obtain good results, we will be able to offer new therapeutic options for patients who do not respond to conventional treatments and even for remission of the disease”, he adds.
The phase Ib/IIa trial will be conducted internationally in 12 patients aged between 18 and 65 with severe lupus unresponsive to standard treatments. In all of them, immune cells will be removed and targeted CAR-Ts will be created and infused again.
Phase Ib/IIa study will be conducted internationally in 12 patients aged 18 to 65 years with severe lupus
Subsequently, they will be followed up for two years. Centers in Spain, France, Germany and Australia are participating in the study. In our country, there are the Vall d’Hebron and the Gregorio Marañón General University Hospital in Madrid.