Clinical Trials

Inclusion Criteria:

• Eligible to receive donor-derived MT-401 following first allogeneic HSCT, are in ≤ second complete remission (CR2), and are MRD negative prior to transplant (including matched sibling, matched unrelated donor 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 90 days (±10 days) post-HSCT defined as patients with CRMRD; or
  • Treatment for 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 (Cohorts I and II) and Cohort III defined as patients who fit a majority of the criteria described above for Group 2 only (as determined by the Sponsor).
    • Note: Engraftment must be confirmed post-transplant (absolute neutrophil count > 1000/m^3 without granulocyte colony-stimulating factor for 7 days, donor chimerism ≥ 50%).
  • Are ≥ 18 years of age prior to administration of MT-401.
  • Patients must have donor-derived cells available to make MT-401.
  • 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 ≤ 1.5 X upper limit of normal; aspartate aminotransferase ≤ 3 X upper limit of normal.
  • Renal: Serum creatinine ≤ 2 X upper limit of normal or measured or calculated creatinine clearance ≥ 45mL/min.
  • Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence starting from Screening for T cell infusion until 6 months after the last T cell infusion. Male patients who are sexually active must agree to use a condom during this period.
  • Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant
  • 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 (particularly in cases of high tumor burden) for ≤ 6 months as long as the following criteria are met:
    • Disease assessment including bone marrow biopsy to be performed within 14 days prior to administration of MT-401 (patients may receive MT-401 even if CR is achieved post-bridging therapy but will be analyzed separately; additionally, patients must have ≤ 50% bone marrow blasts);
    • At least 4 half-lives or 1 week has passed after administration of bridging therapy whichever is longer.

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.
• Taking systemic corticosteroids (exception: physiological doses of steroids allowed).
• On other investigational therapy post-HSCT.
• Anti-thymocyte globulin or Campath within 28 days of MT-401 infusion.

Donor Inclusion Criteria:

Donors for allogeneic stem cell transplants must be considered suitable for and consent to stem cell donation, as per the stem cell transplant program's standard operating procedures. If a donor has been chosen for the transplant, that same donor will also be used for T cell generation provided that there are no new reasons for ineligibility since the stem cell collection. The donor clearance by the National Marrow Donor Program (NMDP) is acceptable or the donors will be evaluated as per standard institutional guidelines. Leukapheresis material will be collected from the same HSCT donor to manufacture MT-401 for the patient.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.