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

About

Brief Summary

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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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
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

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

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