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
This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing).