Safety of MT-401-OTS in Patients With Relapsed AML or MDS
Eligible age
65+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: Marker Therapeutics, Inc.
You may qualify if…
- ✓ General
- ✓ 1. 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
- ✓ 2. Must have a life expectancy ≥ 12 weeks
- ✓ 3. Must have an ECOG performance status of 0-2
- ✓ 4. Must have available MT-401-OTS product with a ≥ 2/8 HLA match Disease Characteristics
- ✓ 5. For participants with AML:
- ✓ 1. Must have a confirmed diagnosis of AML or MDS/AML per 2022 WHO Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms or 2022 International Consensus Criteria
- ✓ 2. Must have intermediate or high-risk disease based on ELN 2022 criteria.
You may not qualify if…
- ✕ Disease-Related
- ✕ 1. Have leukemic involvement in the CNS
- ✕ 2. Have other extramedullary disease involvement (except hepatosplenic involvement)
- ✕ 3. Have APL Medical Conditions
- ✕ 4. Have primary immunodeficiency
- ✕ 5. Have severe or uncontrolled autoimmune disorder
- ✕ 6. Have a history or presence of clinically relevant CNS pathology, such as epilepsy, seizure, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis
- ✕ 7. Have active malignancies (ie, those that are progressing or have required treatment change in the last 24 months) other than the disease being treated under study. Exceptions to this inclusion include the following:
Where it's recruiting
Source: ClinicalTrials.gov · NCT06552416 · last updated 2025-12-16