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

Inclusion Criteria

First allogeneic HSCT, in ≤ CR2, and MRD negative prior to transplant (including matched sibling, MUD with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as:

Adjuvant therapy for AML (Group 1) at 85-130 days post-HSCT defined as patients with CRMRD; or

Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as

First relapse (MRD+ or frank relapse) post-HSCT
Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post HSCT
Safety Lead-in defined as patients who fit all the criteria for Group 2 only
Are ≥18 years of age
Karnofsky/Lansky score of ≥60
Life expectancy ≥12 weeks

Adequate blood, liver, and renal function

Blood: Hemoglobin ≥7.0 g/dL (can be transfused)
Liver: Bilirubin ≤2X upper limit of normal; aspartate aminotransferase ≤3X upper limit of normal
Renal: Serum creatinine ≤2X upper limit of normal or measured or calculated creatinine clearance ≥45mL/min

7. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant.

8. In Group 2, patients may receive bridging therapy at the investigators' discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit

Exclusion Criteria

Clinically significant or severely symptomatic intercurrent infection
Pregnant or lactating
For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401
For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401
Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401