New CAR-T cell therapy for previously treated follicular lymphoma or marginal zone lymphoma

Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are both diseases belonging to the group of B-cell non-Hodgkin lymphomas (NHL). These conditions involve the malignant transformation of immune system cells (B lymphocytes). The causes of NHL are usually unknown, but genetic and environmental factors may play a role. Standard treatment for NHL often involves a combination of immunotherapy and chemotherapy. For patients whose disease no longer responds to these standard treatments, experimental treatment options are being tested. Lisocabtagen-Maraleucel is a CAR-T cell therapy in which the patient’s own immune cells—known as T cells—are genetically modified so that they can subsequently target and attack cancer cells.

The goal of the TRANSCEND FL study is to investigate the efficacy of treatment with lisocabtagen-maraleucel in patients with refractory or relapsed follicular lymphoma or marginal zone lymphoma. It consists of three phases: preparatory therapy involving the collection of T-cells, treatment with lisocabtagen-maraleucel, and long-term follow-up to evaluate efficacy and side effects over approximately 60 months. The six-day preparatory chemotherapy regimen with fludarabine and cyclophosphamide is intended to enhance the effectiveness of the CAR-T cell therapy. Lisocabtagen-Maraleucel is administered intravenously; direct follow-up lasts for 29 days. The study design is single-arm and open-label, as all patients receive the same treatment and are aware of it.

Data from this study have already led to the drug’s approval in the United States. However, the study is continuing to gather even more data on efficacy and safety.

Women and men who are at least 18 years old and have already received one (FL) or two (MZL) standard treatments (including an anti-CD20 antibody), as well as those with good organ function and physical fitness, are eligible to participate in the study.