New CAR-T-Cell Therapy for Follicular Lymphoma

Follicular lymphoma (FL) is a malignant disease of the lymphatic system and is classified as a non-Hodgkin lymphoma. It is characterized by the uncontrolled proliferation of B lymphocytes. Lymphocytes are a type of white blood cell that is part of the body’s immune system. Symptoms of the disease may include fatigue, anemia, weight loss, fever, night sweats, and swollen lymph nodes. The causes of this disease are not fully understood, but genetic and immunological factors play a role. Treatment is usually necessary only when symptoms appear or there is significant lymph node enlargement, and it typically consists of combination immunochemotherapy, which is usually effective. Nevertheless, the disease may become active again after initial treatment (recurrence) or may not respond adequately to treatment (refractory), in which case further treatment options are necessary.

A relatively new form of therapy is treatment with CAR-T cells. This approach uses the patient’s own immune cells (T cells). These are extracted from the blood and genetically modified so that they effectively combat the lymphoma once they are reintroduced into the patient’s body.

The goal of this Phase 3 study is to investigate the efficacy and safety of treatment with axicabtagen-ciloleucel compared to standard therapy in a larger number of patients. Axicabtagen-ciloleucel is a form of CAR-T cell therapy. Axicabtagen-Ciloleucel is currently approved for the treatment of diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma. These are additional subtypes of non-Hodgkin lymphoma. As part of the study, participants will be randomly assigned to one of two groups. Group 1 will first receive pretreatment with chemotherapy (cyclophosphamide + fludarabine) administered as an infusion over 3 days. The goal of this pre-treatment is to reduce the number of cancer cells. This is followed by a single infusion of the study drug, axicabtagen-ciloleucel. Patients in Group 2 receive standard treatment, which is selected by the medical staff as appropriate. The study is open-label, meaning that both the medical staff and the patient know which medications are being administered. The study will continue for up to 5 years, during which the efficacy of the therapy and the occurrence of side effects from the various medications will be evaluated. A key factor is whether or when the disease progresses again during treatment. The primary endpoint of the study is survival without recurrence of FL. Patients who have received the study medication may also be enrolled in a long-term follow-up study, in which follow-up examinations are planned for up to 15 years after the start of therapy.

Patients aged 18 and older with relapsed or refractory FL are eligible to participate in this study.