Expanding the reach of CAR-T therapy
With decades of experience in cell manufacturing and research, our clinical programs advance next-generation CAR-T therapies into new treatment areas.
Expanding the reach of CAR-T therapy
With decades of experience in cell manufacturing and research, our clinical programs advance next-generation CAR-T therapies into new treatment areas.
Disease & Unmet Need
Addressing high unmet needs in oncology and autoimmunity
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL), accounting for ~30–40% of cases.¹ While many patients have been cured with historical standards of care, up to 40% relapse or fail to respond.² Novel approaches such as CAR-T therapy have demonstrated to improve these outcomes, with more therapies in investigation.
Severe autoimmune diseases such as systemic lupus erythematosus (SLE) and systemic sclerosis remain difficult to treat, with many patients failing to achieve long-term remission despite standard immunosuppressive or B-cell–depleting therapies. Academic research has shown that CD19-directed CAR-T therapy can induce remission in patients with severe autoimmune diseases, as reported in the CASTLE trial (NCT06347718).³ Miltenyi Biomedicine is now advancing these pioneering findings, evaluating MB-CART19.1 as a potential new treatment approach for autoimmune disorders.
Our Clinical Program
Investigating CAR-T therapies across different disease areas
Our programs are designed to expand the reach of CAR-T cell therapy to patients with high unmet needs, extending the therapeutic areas beyond oncology.
Zamtocabtagene autoleucel (zamto-cel): a tandem CD19-CD20 (directed) CAR-T therapy in pivotal trials for relapsed/refractory DLBCL. The DLBCL cohorts completed enrollment while new cohorts are actively recruiting (NCT04792489, NCT04844866, NCT06508931).
MB-CART19.1: a CD19 (directed) CAR-T in clinical development for autoimmune disorders, including systemic lupus erythematosus (NCT06189157).
View our clinical trials
Technology & Manufacturing
Manufacturing built on decades of cell therapy expertise
Our investigational therapy candidates including zamto-cel and MB-CART19.1 are manufactured on Miltenyi Biotec’s CliniMACS Prodigy® platform. The automated, closed-system technology reduces variability and supports reproducible, GMP-compliant CAR-T manufacturing at scale. This foundation helps ensure reliable delivery to certified CAR-T centers.
References: 1) Melchardt, T. et al. ESMO Open; 2) Sehn, L.H., Salles G. NEJM 2021; 3) Mackensen, A. et al. N Engl J Med 2024
“I know I am part of a team that is making a difference in people’s lives“
Emiliano M., Global Marketing Cell & Gene Therapies“I know I am part of a team that is making a difference in people’s lives“
Emiliano M., Global Marketing Cell & Gene Therapies
References: 1) Melchardt, T. et al. ESMO Open; 2) Sehn, L.H., Salles G. NEJM 2021; 3) Mackensen, A. et al. N Engl J Med 2024