Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06552416 | Safety of MT-401-OTS in Patients With Relapsed AML or MDS | PHASE1 | RECRUITING | 40 | — | — | Jun 16, 2025 | Sep 1, 2029 | Dec 16, 2025 | 3 | United States |
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...