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

Trial details

Who runs it

Marker Therapeutics, Inc.

Trial code

NCT04511130

Record updated

30 October 2025

Original description

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).Read full original descriptionShow less

A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients With Acute Myeloid Leukemia (AML) Following Hematopoietic Stem Cell Transplantation

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).

Inclusion: 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: 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; Clinically significant or severely symptomatic intercurrent infection; Pregnant or lactating.

ClinicalTrials.gov NCT04511130