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Zedenoleucel · MT-401

Cell therapy · Kills target cells, directed at WT1, PRAME and NY-ESO-1 (CTAG1B) · developed by Marker Therapeutics

Phase 2 Most advanced trial
MRKR Developer
2 Registered trials

What is Zedenoleucel?

Zedenoleucel (MT-401) is an off-the-shelf allogeneic T cell therapy composed of donor-derived T lymphocytes engineered to recognize four tumor-associated antigens: WT1, PRAME, NY-ESO-1, and survivin. Upon infusion, the cells recognize and kill cancer cells expressing these antigens. It is studied in acute myeloid leukemia, myelodysplastic syndrome, and post-stem cell transplantation settings.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
MT-401
Drug type
Cell therapy
Targets
WT1 (antigen), PRAME (antigen), NY-ESO-1 (CTAG1B) (antigen), survivin (BIRC5) (antigen)
Mechanism
Kills target cells, directed at WT1, PRAME and NY-ESO-1 (CTAG1B)
Therapy area
Oncology
Developer
Marker Therapeutics, Inc. (MRKR)
FDA status
Investigational, not approved in the US. Most advanced trial: Phase 2
UNII
L4D9X59F34

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT04511130 Phase 2 Acute Myeloid Leukemia Terminated MRKR
NCT06552416 Phase 1 Acute Myeloid Leukemia, in Relapse Recruiting MRKR

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Acute Myeloid Leukemia, in RelapseMDSAcute Myeloid LeukemiaStem Cell Transplantation

More from Marker Therapeutics

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.