Drugs / MB-CART2019.1
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07178431 | Apr 2026 → Aug 2030 expected | multiple sclerosis | Miltenyi Biomedicine GmbH | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07288879 | Dec 2025 → Jan 2027 expected | diffuse large B-cell lymphoma | Miltenyi Biomedicine GmbH | Recruiting | No outcome recorded |
| Phase 2 | NCT04844866 | Aug 2021 → Jan 2025 overdue | diffuse large B-cell lymphoma | Miltenyi Biomedicine GmbH | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06508775 | May 2024 → Dec 2040 expected | childhood acute lymphoblastic leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, melanoma | Miltenyi Biomedicine GmbH | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-05-28 | Miltenyi Biomedicine GmbH | Regulatory Miltenyi Biomedicine Submits Marketing Authorization Application for zamto-cel to the EMA miltenyibiomedicine.com ↗
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. |
| 2025-12-07 | Miltenyi Biomedicine GmbH | Results Miltenyi Biomedicine presents primary analysis of the pivotal DALY 2-EU trial for second-line relapsed / refractory large B-cell lymphoma at the 67th American Society of Hematology (ASH) Annual Meeting miltenyibiomedicine.com ↗
The primary analysis showed that zamto-cel demonstrated significant and clinically meaningful superiority over chemoimmunotherapy (R-GemOx) in transplant-ineligible patients who were at a high risk of rapid disease progression. |
| 2024-12-07 | Miltenyi Biomedicine GmbH | Results Miltenyi Biomedicine will share positive interim results from DALY II USA at the American Society of Hematology (ASH) Annual Meeting miltenyibiomedicine.com ↗
The pre-planned interim analysis showed that zamto-cel has a favorable safety profile and promising overall response rate (ORR) and complete response rate (CRR) in patients with R/R DLBCL. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-28 | Miltenyi Biomedicine GmbH | Miltenyi Biomedicine Submits Marketing Authorization Application for zamto-cel to the EMA miltenyibiomedicine.com ↗ |
| 2025-12-07 | Miltenyi Biomedicine GmbH | Miltenyi Biomedicine presents primary analysis of the pivotal DALY 2-EU trial for second-line relapsed / refractory large B-cell lymphoma at the 67th American Society of Hematology (ASH) Annual Meeting miltenyibiomedicine.com ↗ |
| 2025-11-03 | Miltenyi Biomedicine GmbH | Miltenyi Biomedicine announces new zamtocabtagene autoleucel data to be presented at ASH 2025 miltenyibiomedicine.com ↗ |
| 2024-12-07 | Miltenyi Biomedicine GmbH | Miltenyi Biomedicine will share positive interim results from DALY II USA at the American Society of Hematology (ASH) Annual Meeting miltenyibiomedicine.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MB-CART2019.1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07178431 ↗ |
| Known as | zamtocabtagene autoleucel | “DALY II Japan is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with...” NCT07288879 ↗ |
| Modality | Cell therapy | “MB-CART2019.1 consists of autologous cluster of differentiation CD20/CD19 chimeric antigen receptor (CAR) transduced CD4/CD8 enriched T cells” NCT04844866 ↗ |
| Route | Intravenous | “Cell infusion will be administered intravenously” NCT07288879 ↗ |