Drugs / ZEDENOLEUCEL
ZEDENOLEUCEL
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | acute megakaryoblastic leukemia in adult | 2021-01-05 | “today announced that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on the Company's Phase 2 trial investigating the safety and efficacy of MT-401” markertherapeutics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04511130 | Oct 2020 → Mar 2024 | acute myeloid leukemia, disease related to hematopoietic stem cell transplant | Marker Therapeutics, Inc. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2025-10-06 | Marker Therapeutics, Inc. | Results Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program markertherapeutics.com ↗
The therapy was well tolerated with no treatment-related adverse events. |
| 2024-01-08 | Marker Therapeutics, Inc. | Results Marker Therapeutics Announces Clinical Program Updates and Pipeline Prioritization markertherapeutics.com ↗
In addition, the Company reported a clinical update on the Phase 2 ARTEMIS study investigating MT-401, a multiTAA-specific T cell product, for the treatment of patients with acute myeloid leukemia (AML). |
| 2023-07-10 | Marker Therapeutics, Inc. | Regulatory European Medicines Agency Grants Orphan Drug Designation for MT-401 developed by Marker Therapeutics for the Treatment of AML Patients markertherapeutics.com ↗
Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, announced that zedenoleucel, its multi-tumor-associated antigen (multiTAA)-specific T cell product candidate, MT-401, was granted Orphan Drug Designation by the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) for the treatment of patients with acute myeloid leukemia (AML). |
| 2023-06-26 | Marker Therapeutics, Inc. | Results Marker Therapeutics Reports MT-401 Non-Clinical Data in AML Cells after Hypomethylating Agent Administration markertherapeutics.com ↗ |
| 2022-02-16 | Marker Therapeutics, Inc. | Results Marker Therapeutics Announces Clinical Program Updates and Pipeline Expansion markertherapeutics.com ↗
The results of the safety lead-in stage of the Marker Phase 2 AML trial support the potential for MT-401 as a treatment option for patients with AML in the post-transplant setting. |
| 2021-07-06 | Marker Therapeutics, Inc. | Results Marker Therapeutics Announces Completion of Safety Lead-In Portion of Phase 2 Study in Post-Transplant AML markertherapeutics.com ↗ |
| 2021-01-05 | Marker Therapeutics, Inc. | Regulatory Marker Therapeutics Announces FDA Lifted Partial Clinical Hold on Phase 2 AML Clinical Trial markertherapeutics.com ↗ |
| 2020-06-23 | Marker Therapeutics, Inc. | Regulatory Marker Therapeutics Receives USAN Approval for "zelenoleucel" as Nonproprietary Name for MT-401, Multi-Tumor-Associated Antigen Targeted T Cell Product for Acute Myeloid Leukemia markertherapeutics.com ↗ |
| 2020-04-29 | Marker Therapeutics, Inc. | Regulatory Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Acute Myeloid Leukemia markertherapeutics.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZEDENOLEUCEL | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650493 ↗ |
| Known as | MT-401 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04511130 ↗ |
| Known as | Zelenoleucel | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650493 ↗ |
| Modality | Cell therapy | “allogeneic multi-tumor-associated antigen (MultiTAA)-specific T cell product” NCT04511130 ↗ |