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

ConditionsAcute Myeloid Leukemia, in RelapseMDS
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • MT-401-OTS

    Drug

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

Treatment groups

40 Participants
are divided into 5 treatment groups
Group A: Cohort -1Experimental treatment 1 intervention
Group B: Cohort 1Experimental treatment 1 intervention
Group C: Cohort 2Experimental treatment 1 intervention
Group D: Cohort 3Experimental treatment 1 intervention
Group E: Cohort 4 (optional)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of MT-401-OTS

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

Time frame
Through study completion. Approximately 5 years
2

Tolerability of MT-401-OTS

cGVHD per 2014 NIH consensus criteria for cGVHD

Time frame
Through study completion. Approximately 5 years

Secondary outcomes

1

To assess the efficacy of MT-401-OTS in participants with high-risk or very-high-risk MDS per IPSS-M who have evidence of disease following at least 4 cycles of a HMA

Per 2023 IWG criteria for higher-risk MDS: * CR rate * DOCR * ORR * DOR

Time frame
Following conclusion of the disease assessment of last MDS subject treated. Approximately 2 years
2

To assess the efficacy of MT-401-OTS in participants with intermediate or high-risk AML per 2022 ELN criteria who have evidence of disease following induction therapy or at least 4 cycles of nonintensive treatment

Per 2022 ELN Criteria for AML: * Rate of MRD negativity * CR, DOCR * ORR, DOR

Time frame
Following conclusion of the disease assessment of last AML subject treated. Approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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