Drugs / zamtocabtagene autoleucel
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | large B-cell lymphoma | 2026-05-28 | “has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for zamtocabtagene autoleucel” miltenyibiomedicine.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06708845 | Jul 2026 → Jan 2028 expected | diffuse cutaneous systemic sclerosis, lupus nephritis, systemic lupus erythematosus | Miltenyi Biomedicine GmbH | Recruiting | No outcome recorded |
| Phase 1 | NCT03870945 | Feb 2019 → Dec 2020 | B-cell non-Hodgkin lymphoma | Miltenyi Biomedicine GmbH | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07569965 | Sep 2026 → Sep 2029 expected | mantle cell lymphoma | Miltenyi Biomedicine GmbH | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06508931 | Aug 2025 → Dec 2029 expected | B-cell neoplasm | Miltenyi Biomedicine GmbH | Recruiting | No outcome recorded |
| Phase 2 | NCT04792489 | May 2021 → Dec 2026 expected | Richter transformation, central nervous system non-hodgkin lymphoma, high grade B-cell lymphoma, mantle cell lymphoma +1 | Miltenyi Biomedicine GmbH | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| 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. |
| 2025-11-03 | Miltenyi Biomedicine GmbH | Results Miltenyi Biomedicine announces new zamtocabtagene autoleucel data to be presented at ASH 2025 miltenyibiomedicine.com ↗
DALY 2-EU study demonstrate a statistically significant and clinically meaningful increase in event free survival in relapsed/refractory diffuse large B-cell lymphoma. |
| 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 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zamtocabtagene autoleucel | “Zamtocabtagene autoleucel in relapsed/refractory B-NHL: 5-year follow-up of a CD20/19 tandem CAR T-cell phase 1 trial.” PMID 41512222 ↗ Apr 2026 |
| Known as | MB-CART2019.1 | “the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory B cell lymphoma” NCT04792489 ↗2“Zamtocabtagene autoleucel (MB-CART2019.1) is a tandem CD20-CD19-directed non-cryopreserved CAR-T cell therapy.” NCT06508931 ↗ “zamtocabtagene autoleucel (MB-CART2019.1)” NCT07569965 ↗ |
| Known as | zamto-cel | “AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non...” NCT06708845 ↗1“first-in-human phase 1 clinical trial of zamtocabtagene autoleucel (zamto-cel), a noncryopreserved tandem CD20-CD19-directed CAR T-cell therapy” PMID 41512222 ↗ Apr 2026 |
| Modality | Cell therapy | “a noncryopreserved tandem CD20-CD19-directed CAR T-cell therapy” PMID 41512222 ↗ Apr 2026 |
| Route | Intravenous | “The IMP will be administered as an intravenous infusion.” NCT03870945 ↗ |
| Target | CD19 | “genetically modified to express anti-CD20 and CD19 immunoreceptor” NCT03870945 ↗ |