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

Stopped early · Phase 2

Conditions studied: Acute Myeloid Leukemia, Stem Cell Transplantation

In brief

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).

Key facts

Study ID

NCT04511130

Run by

Marker Therapeutics, Inc.

People needed

92

Starts

2020-10-14

Expected to finish

2024-03-01

Last updated by the study team

2025-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• Moores Cancer Center at University of Californa San Diego — La Jolla, California, United States
• UCLA Department of Medicine — Los Angeles, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Mayo Clinical Cancer Center-Florida — Jacksonville, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Mayo Clinic Cancer Center-Rochester — Rochester, Minnesota, United States
• John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States
• Weill Cornell Medicine | NewYork-Presbyterian — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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