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MT-401-OTS · 1 trial · 2 indications
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
cGVHD per 2014 NIH consensus criteria for cGVHD
| Arm | Type | Description |
|---|---|---|
| Cohort -1 | EXPERIMENTAL | 50 × 106 cells flat dose, 1 dose infused on Day 0 |
| Cohort 1 | EXPERIMENTAL | 100 × 106 cells flat dose, 1 dose infused on Day 0 |
| Cohort 2 | EXPERIMENTAL | 200 × 106 cells flat dose, 1 dose infused on Day 0 |
| Cohort 3 | EXPERIMENTAL | 400 × 106 cells flat dose, 1 dose infused on Day 0 |
| Cohort 4 (optional) | EXPERIMENTAL | up to 400 × 106 cells flat dose TBD based on data from Cohorts 1-3; may include split dosing, dosing with or without lymphodepleting conditioning regimen, or dosing with or without HMA |
| Name | Type | Description |
|---|---|---|
| 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. |
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 h...
MT-401-OTS is an investigational small molecule being studied for the treatment of acute myeloid leukemia (AML) in relapse. It is also being evaluated in patients with myelodysplastic syndromes (MDS). The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
MT-401-OTS targets tumor antigens, specifically survivin, PRAME, NY-ESO-1, and WT-1. These are proteins that are often overexpressed in cancer cells and are being studied as potential targets for treating relapsed acute myeloid leukemia and MDS.
MT-401-OTS is being developed by Marker Therapeutics, Inc. (NASDAQ: MRKR). The company is conducting a Phase 1 clinical trial to evaluate the safety of this investigational drug in patients with relapsed AML or MDS.
MT-401-OTS is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received orphan drug designation, which is granted to therapies intended to treat rare diseases.
MT-401-OTS is being studied in a Phase 1 clinical trial with the identifier NCT06552416. This trial is recruiting 40 patients with relapsed acute myeloid leukemia or MDS in the United States. The study is open to patients aged 65 years and older and is not randomized or double-blinded.