Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 cell therapy being developed by Marker Therapeutics, Inc. for acute myeloid leukemia in relapse. It is designed to recognize multiple tumor antigens and is currently in Phase 1 clinical testing. It has received an orphan drug designation from the FDA.
MT-401-OTS is being studied for the treatment of acute myeloid leukemia in relapse, and the ongoing trial also enrolls patients with myelodysplastic syndromes. It is an investigational product and has not been approved for any indication. Testing is limited to relapsed disease in patients aged 65 years and older.
MT-401-OTS targets the tumor antigens survivin, PRAME, NY-ESO-1, and WT-1. These antigens are expressed on malignant cells in acute myeloid leukemia, and the product is designed to direct a therapeutic response against cells presenting them. The trial is biomarker selected, meaning patients are screened for relevant antigen expression.
MT-401-OTS is being developed by Marker Therapeutics, Inc., which trades on the Nasdaq under the ticker MRKR. The company is the sponsor of the ongoing Phase 1 study of the product in relapsed acute myeloid leukemia and myelodysplastic syndromes.
MT-401-OTS is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The FDA has granted it an orphan drug designation, which is a status separate from marketing approval.
MT-401-OTS is being evaluated in the Phase 1 trial NCT06552416, titled Safety of MT-401-OTS in Patients With Relapsed AML or MDS. The study is currently recruiting in the United States, plans to enroll 40 patients, and is controlled but not randomized or double blinded.