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MT-401-OTS for Relapsed AML or MDS

This study is testing the safety and tolerability of a new treatment called MT-401-OTS. This treatment is an "off-the-shelf" cell therapy given through an IV. It's designed as a targeted therapy. You might be able to join if you are 65 or older and have Acute Myeloid Leukemia (AML) that has come back, or high-risk Myelodysplastic Syndromes (MDS) with remaining disease after prior treatment. The study aims to enroll 40 participants and will follow your safety for about 5 years. This is a Phase 1 study, meaning it's an early step to see how safe the treatment is.

Study design
This is a Phase 1, open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll 40 participants.
What's involved
You will receive a conditioning regimen of chemotherapy (fludarabine and cyclophosphamide, or bendamustine) followed by two doses of HMA (azacitidine or decitabine), then the MT-401-OTS infusion. Safety and disease assessments will be done regularly.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored throughout the study, which is expected to last approximately 5 years.

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NCT06552416

Safety of MT-401-OTS in Patients With Relapsed AML or MDS

Recruiting
PHASE1Ages 65+InterventionalTreatment
Marker Therapeutics, Inc.
~40 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:MT-401-OTS

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of MT-401-OTS
Measured over Through study completion. Approximately 5 years
+1 more outcome measured

Conditions

Acute Myeloid Leukemia, in Relapse
MDS

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic SyndromeHLA Complex

Where it's being run

3 sites across 3 states
California1
Florida1
Kansas1

Who to contact

Patricia Allison, BS
[email protected]
713-400-6400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

General

Exclusion

Disease-Related

What this trial measures

  • Safety of MT-401-OTSThrough study completion. Approximately 5 years

    Assess: * Incidence of DLTs to determine the RP2D * Safety (including but not limited to): TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE, Version 5.0 * Acute GVHD per 2016 MAGIC criteria * CRS and ICANS per ASTCT criteria

  • Tolerability of MT-401-OTSThrough study completion. Approximately 5 years

    cGVHD per 2014 NIH consensus criteria for cGVHD