Safety of MT-401-OTS in Patients With Relapsed AML or MDS
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65+
SponsorMarker Therapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
General
Must be ≥ 65 years of age and capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF
Must have a life expectancy ≥ 12 weeks
Must have an ECOG performance status of 0-2
Disqualifiers
Disease-Related
Have leukemic involvement in the CNS
Have other extramedullary disease involvement (except hepatosplenic involvement)
Have APL Medical Conditions
Trial design
Treatments tested in this trial
- MT-401-OTS
Treatment groups
40 Participants
are divided into 5 treatment groupsSponsors and collaborators
Marker Therapeutics, Inc.
Lead sponsor
University of Kansas Medical Center
Collaborator
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
City of Hope National Medical Center
Collaborator
FDA Office of Orphan Products Development
Collaborator
Source ClinicalTrials.gov