Bergisch Gladbach, May 21th, 2026, Miltenyi Biomedicine has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for zamtocabtagene autoleucel (zamto cel) for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBL), primary mediastinal large B-cell lymphoma (PMBCL) and transformations of indolent B-cell lymphomas who relapsed within 24 months from start of, or are refractory to, first-line chemoimmunotherapy.

The EMA has validated the application, which is now under review. Zamto cel is the first cell therapy from Miltenyi Biomedicine’s pipeline to reach this regulatory milestone.

Zamto cel represents the first autologous second generation CAR T therapies, engineered to simultaneously target two antigens, CD20 and CD19. The tandem dual targeting CD20-CD19 CAR T design aims to overcome resistance mechanisms associated with earlier single antigen CAR T approaches. If approved, zamto cel is intended to be the first commercially available fresh (non cryopreserved) CAR T product. This fresh delivery model, paired with a fixed 12-day manufacturing process, is designed to enable rapid delivery and support shorter vein-to-vein times for patients.

Manufacturing is performed at Miltenyi Biotec’s CliniMACS Cell Factory® in Bergisch Gladbach near Cologne, Germany, ensuring reliable supply and proximity to European treatment centers.

This Marketing Authorization Application is supported by the pivotal DALY 2 EU study, comprising 168 randomized patients enrolled at 42 clinical trial sites across 12 European countries.¹ In this study, zamto cel demonstrated statistically significant improvements in event free survival compared with standard therapy (R-GemOx) and showed a favorable safety profile in a clinically high risk patients with relapsed or refractory LBCL and transformed lymphomas.²

Miltenyi Biomedicine has submitted its dossier to the EMA and, in parallel to Swissmedic in Switzerland. Regulatory filings for zamto cel are also in preparation for the U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). In both regions, decentralized, multi-site manufacturing is planned to enable rapid delivery and broad patient access.

About Miltenyi Biomedicine
Miltenyi Biomedicine is committed to making innovative cancer treatments and regenerative therapies accessible to patients with serious diseases. Leveraging cutting-edge technology, the company innovates independently to address hard-to-treat blood cancers and harness the potential of CAR technology to transform patient care.

About CliniMACS Cell Factory®
The GMP-certified CliniMACS Cell Factory® is a scalable manufacturing concept for cell and gene therapies. It is based on automated systems, standardized processes, and quality controls implemented across a network of sites. Developed by Miltenyi Biotec, a global leader in innovating technologies and services for patient-specific cell and gene therapies, its decentralized setup enables consistent production across regions and supports local manufacturing to facilitate patient access.

Media contact
Miltenyi Biomedicine
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach, Germany
[email protected]

References

1. ClinicalTrials.Gov. Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients (DALY 2-EU). Available at: https://clinicaltrials.gov/study/NCT04844866. [last access: March 2026]
2. Borchmann P, et al. Zamtocabtagene-autoleucel, a tandem CD20-CD19 directed CAR-T cell therapy as second-line treatment for Relapsed/Refractory large B-cell lymphoma: primary analysis of the randomized pivotal DALY 2-EU study. Presented at American Society of Hematology (ASH) Annual Meeting. Abstract #abs25-738.

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