Safety of MT-401-OTS in Patients With Relapsed AML or MDS
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. 3. If no targetable mutation is present, must have received 1 prior standard regimen with at least 4 cycles of standard therapy containing an HMA or a standard cytarabine-containing induction therapy 4. If targetable mutation is present, must have received a regimen that includes c