Observational study on the safety, tolerability, and efficacy of a previously administered CAR-T cell therapy using CAR-T cells from the pharmaceutical company Miltenyi

A highly acclaimed new form of therapy is CAR-T cell therapy, which is used to treat various diseases such as blood cancers and skin cancer. In this type of therapy, T cells—a specific type of the body’s own immune cells—are extracted from patients and genetically modified so that they can recognize cancer cells and target them specifically. These cells are then reintroduced into the patients. The therapy is already approved for various conditions, and several pharmaceutical companies produce CAR-T cells, including Miltenyi. Since this form of therapy has not been available for very long, there is currently a lack of sufficient data on its long-term efficacy and safety.

The goal of the LONGSAFE study is to examine and monitor patients who have been treated with CAR-T cell therapy using a CAR-T cell drug from the pharmaceutical company Miltenyi Biotec in order to gather additional long-term data on safety and efficacy (drugs: Zamtocabtagene autoleucel, MB-CART19.1, and MB-CART2219.1). This follow-up will continue for up to 14 years. The study will also monitor the development of children who have been treated with CAR-T cell therapy. The study is purely observational and does not involve any new treatment methods.

Female and male patients of any age group may participate in the study if they have been treated with a CAR-T cell therapy from the pharmaceutical company Miltenyi. This treatment must have taken place at least 12 months ago. The conditions eligible for the study are acute lymphoblastic leukemia (ALL), childhood ALL, lymphomas (in children or adults), chronic lymphocytic leukemia (CLL), and skin cancer (stages 3 and 4).