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

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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
No
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 90 days (±10 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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Study Stats
Protocol No.
21-000218
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04511130
For detailed technical eligibility, visit ClinicalTrials.gov.