Clermont-Ferrand University Hospital announces a major breakthrough in the management of adult systemic lupus erythematosus: the launch of an international clinical trial using a cutting-edge therapy, CAR-T cells.
This trial is coordinated by Dr Ludovic Trefond within the Auvergne Reference Center for Rare Systemic Autoimmune and Autoinflammatory Diseases, led by Professor André, in the internal medicine department at the Gabriel-Montpied site of Clermont-Ferrand University Hospital. It is conducted in collaboration with Dr Aurore Douge, from the CLIP2 early-phase oncology and cell therapy unit, and the adult clinical hematology department headed by Professor Jacques Olivier Bay.
This initiative positions the hospital as the first institution in the Auvergne-Rhône-Alpes region to offer administration of this groundbreaking treatment to adult patients with systemic lupus erythematosus.
A complex disease requiring new therapeutic solutions
Systemic lupus erythematosus is a rare autoimmune disease. This means that the immune system, which is supposed to protect the body, becomes dysregulated and mistakenly attacks the patient’s own organs. It is a chronic and potentially serious condition when it affects vital organs such as the kidneys, brain, heart, or lungs. In patients for whom standard treatments are not sufficiently effective, the disease can lead to significant complications, with a risk of long-term damage or even death.
For many years, treatments mainly aimed to control the disease by reducing flare-ups and limiting organ damage. However, a new therapeutic strategy is now redefining prospects for patients with the most severe forms of the disease.
CAR-T cells: a revolution originating from oncology
CAR-T cells (Chimeric Antigen Receptor T-cells) are an innovative therapy initially developed to treat certain blood diseases. The principle is as follows: specific white blood cells from the patient, called T lymphocytes, are collected and then modified in the laboratory to enable them to recognize and eliminate specific cells involved in the disease. These “reprogrammed” cells are then reinfused into the patient.
Given the remarkable success of this approach in hematology, it has been explored in certain severe autoimmune diseases, such as lupus, when conventional treatments are not sufficiently effective. The first clinical trials have shown particularly promising results:
- targeted elimination of the cells responsible for the disease (certain abnormal B lymphocytes);
- a rapid and sustained reduction in inflammation;
- prolonged symptom-free periods, potentially lasting several years without additional treatment;
- improvement, or even resolution, of certain severe complications, particularly kidney involvement (lupus nephritis);
- generally manageable side effects, most often limited to a transient inflammatory reaction known as “cytokine release syndrome.”
These results represent a major breakthrough: for the first time, a treatment could correct the underlying immune dysfunction rather than simply controlling the symptoms.
Clermont-Ferrand University Hospital joins authorized centers in France
Until now, only eight French centers (Bordeaux, Paris and Strasbourg, Toulouse, Nancy, Nantes, and Marseille) were participating in the phase 1/2 clinical trial. Clermont-Ferrand University Hospital has been granted authorization to take part, paving the way for regional access to one of the most innovative therapies in modern medicine.
The clinical trial involves several stages:
- Cell collection: certain white blood cells are collected from the patient using a technique called apheresis (similar to blood donation);
- Laboratory preparation: these cells are then modified in a specialized laboratory to become CAR-T cells;
- Preparation phase: a treatment is administered to prepare the body to receive these new cells (lymphodepletion);
- Injection: the CAR-T cells are reinfused into the patient;
- Action in the body: once inside the body, these cells multiply and target the cells responsible for the disease.
The aim of this approach is to “reset” the immune system so that it can function normally again, with healthy cells.
Emphasizes Dr Ludovic Trefond, hospital practitioner in the internal medicine department at the Gabriel-Montpied site of the University Hospital and principal investigator for the protocol.We are extremely proud to offer this opportunity to our patients. Access to such an innovative therapy represents a historic turning point in the management of severe lupus. For patients with no remaining treatment options, it offers a real hope of long-term remission.
