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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-06-16 |
| Est. Completion | 2029-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06552416
The ClinicalTrials.gov registry entry for NCT06552416 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 95-participant average among 22 other MDS trials with a reported enrollment target (58% lower). The listed sponsor is Marker Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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