OncoMatch/Clinical Trials/NCT06552416
Safety of MT-401-OTS in Patients With Relapsed AML or MDS
Is NCT06552416 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies MT-401-OTS for acute myeloid leukemia, in relapse.
Treatment: MT-401-OTS — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent — AML: if no targetable mutation, 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; MDS: must have received standard treatment with at least 4 cycles of an HMA
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 (AML); Must have received standard treatment with at least 4 cycles of an HMA (MDS)
Must have received: cytarabine-containing induction therapy — AML: if no targetable mutation
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
Must have received: targeted therapy — AML: if targetable mutation present
If targetable mutation is present, must have received a regimen that includes commercially available targeted therapy unless unable to tolerate or the participant declines (must be documented in the informed consent). If targeted therapy was not administered as part of first-line of therapy, a second regimen is allowed.
Cannot have received: hematopoietic stem cell transplant
Have had prior HSCT
Lab requirements
Blood counts
PT/INR and PTT/aPTT < 1.3 × ULN
Kidney function
eGFR ≥ 40 mL/min by the MDRD formula
Liver function
AST and ALT < 3 × ULN; for participants with leukemic infiltration of the liver (documented by biopsy or imaging), AST and ALT < 5 × ULN is permitted. Total bilirubin ≤ 1.5 × ULN unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin (2 × ULN is permitted)
Cardiac function
LVEF ≥ 45% (prior to apheresis and lymphodepletion)
Must have adequate coagulation, hepatic, renal, and cardiac function: PT/INR and PTT/aPTT < 1.3 × ULN; AST and ALT < 3 × ULN; for participants with leukemic infiltration of the liver (documented by biopsy or imaging), AST and ALT < 5 × ULN is permitted. Total bilirubin ≤ 1.5 × ULN unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin (2 × ULN is permitted); eGFR ≥ 40 mL/min by the MDRD formula; LVEF ≥ 45% (prior to apheresis and lymphodepletion)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center) · Duarte, California
- Moffitt Cancer Center · Tampa, Florida
- KU Cancer Center · Kansas City, Kansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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