Disease areas
We are investigating cell therapies across oncology and in diseases where CAR-T approaches show strong potential, including autoimmune conditions. Our current development focus is hematologic malignancies, initially large B-cell lymphomas, with additional disease areas under evaluation as our pipeline expands.
Hematologic malignancies
Our lead focus is on hematological malignancies, particularly diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of non-Hodgkin lymphoma, accounting for ~30–40% of B-cell NHL¹. Although incidence rises with age, it can occur across all age groups.²
Approximately 70% of patients present with advanced-stage disease, where treatment typically relies on systemic therapy. ³
While many patients achieve cure with current standards of care, relapsed/refractory disease remains a significant unmet need, driving the investigation of cellular immunotherapies such as CAR-T3.
Autoimmune diseases
Autoimmune disorders represent a major area of unmet medical need, where many patients fail to achieve sustained remission despite existing therapies. These conditions are often chronic, systemic, and life-threatening, with limited options once standard approaches fail.
Recent first-in-human studies have demonstrated the feasibility of CD19-directed CAR-T therapy in refractory autoimmune disease. Employing Miltenyi’s platform and reagents, investigators in the CASTLE trial reported remission in patients with systemic lupus erythematosus (SLE), systemic sclerosis, and other severe autoimmune conditions.4-5
These results suggest that CAR-T cells may reset immune tolerance by achieving profound, durable B-cell depletion beyond the reach of conventional treatments.
MB-CART19.1 is Miltenyi Biomedicine’s investigational CD19-directed CAR-T therapy in clinical development for autoimmune disorders. The CASTLE trial (NCT06347718) is serving as the foundation for a structured development program that aims to evaluate zorpo-cel across multiple B-cell–driven autoimmune diseases.
Solid tumors
In addition to hematological malignancies and autoimmune diseases, Miltenyi Biomedicine is developing CAR-T cell therapies for solid tumors, an area with significant unmet clinical need. We are advancing with preclinical programs designed to overcome the unique challenges of the solid tumor microenvironment. Through these efforts, we aim to extend the transformative potential of CAR-T cell therapy to a broader range of cancers.
View our clinical trials on1) Melchardt, T. et al. ESMO Open; 2) Vodicka P. et al. Onco Targets Ther 2022; 3) Sehn, L.H., Salles G. NEJM 2021; 4) Mackensen, A. et al. N Engl J Med 2022; 5) Mackensen, A. et al. N Engl J Med 2024