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NCT06552416 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of MDS and Acute Myeloid Leukemia, in Relapse, sponsored by Marker Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
40
Enrollment target
3
Study locations

NCT06552416: Recruiting Phase 1 study of MDS and Acute Myeloid Leukemia, in Relapse, sponsored by Marker Therapeutics.

NCT06552416 is a Phase 1 study of MDS and Acute Myeloid Leukemia, in Relapse that is actively recruiting participants, run by Marker Therapeutics. The registered enrollment target is 40 participants, below the 95-participant average among 22 other MDS trials with a reported enrollment target (58% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06552416, a Phase 1 study of MDS and Acute Myeloid Leukemia, in Relapse, is actively recruiting participants, sponsored by Marker Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
3
Study locations

Study Summary

This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or \</= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with \</= 10% blasts following treatment with an HMA-based therapy.

Primary Outcome

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

Conditions Studied

MDS Acute Myeloid Leukemia, in Relapse

Interventions

  • DRUG MT-401-OTS

Study Locations (3)

California

  • City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center) - Duarte

Florida

  • Moffitt Cancer Center - Tampa

Kansas

  • KU Cancer Center - Kansas City

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-06-16
Est. Completion 2029-09
Phase Phase 1
Marker Therapeutics

7 total trials

What NCT06552416 shows while recruiting

NCT06552416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 95-participant average among 22 other MDS trials with a reported enrollment target (58% lower).

The record links to 2 conditions, with MDS appearing as the primary indexed condition, and to 1 intervention - of which MT-401-OTS is the first listed.

NCT06552416 reports a single indexed study location in California, Florida, Kansas.

Frequently Asked Questions

What is clinical trial NCT06552416 about?

NCT06552416 is a clinical study titled "Safety of MT-401-OTS in Patients With Relapsed AML or MDS". This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or \</= 10% blast following prior induction therapy ...

What is the current status of trial NCT06552416?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-06-16. Estimated completion is 2029-09.

What conditions does trial NCT06552416 study?

This clinical trial studies the following conditions: MDS, Acute Myeloid Leukemia, in Relapse.

What interventions are being tested in trial NCT06552416?

The interventions under investigation include: MT-401-OTS (DRUG).

Who is sponsoring clinical trial NCT06552416?

This trial is sponsored by Marker Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06552416 being conducted?

This trial has 3 study locations across California, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for MDS

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06552416's enrollment target sits among peer trials

40 11th of 22 higher than 12 of 22 other MDS trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other MDS trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06552416

Source: ClinicalTrials.gov NCT06552416, the US trial registry maintained by the National Library of Medicine. NCT06552416 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.