Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant

This study is in patients aged ≥18 years old undergoing or having relapsed after their first allogeneic HSCT (matched sibling, matched unrelated donor, or haploidentical transplants) for AML.

Potential patients for the study may be screened/enrolled:

• Prior to their first allogeneic HSCT.

or

• Patients experiencing their first relapse post-allogeneic transplant.

Patients eligible for the study will be placed into one of two groups:

* Adjuvant (Group 1): Patients screened prior to their HSCT with CR without minimal residual disease (CRMRD-) at 85-130 days post transplant will be randomized (1:1) in an unblinded fashion to:

* MT-401 (Arm A) * SOC (Arm B) * Active Disease: (Group 2): Patients meeting the following criteria will be assigned to Group 2 and will receive MT 401:

* Patients who experience relapse (patients with MRD \[MRD+\] or frank relapse) at or prior to post-transplant Day 85-130 * Patients in Arm B of Group 1 (SOC) who develop relapse (MRD+ or frank relapse) post-HSCT (crossover patients) * Patients who do not consent prior to HSCT but are experiencing their first relapse (MRD+ or frank relapse) and have the same donor available for manufacturing