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

NCT06552416 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-16

No results posted yet for this 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

  • Acute Myeloid Leukemia, in Relapse
  • MDS

Interventions

DRUG

MT-401-OTS

MT-401-OTS is an off the shelf cellular therapy product given by IV infusion through either a peripheral or central line.

Sponsors & Collaborators

  • University of Kansas Medical Center

    collaborator OTHER

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • City of Hope National Medical Center

    collaborator OTHER

  • FDA Office of Orphan Products Development

    collaborator FED

  • Marker Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2029-09-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06552416 on ClinicalTrials.gov