Novel T-Cell Based Immunotherapy Dosed Phase 2 Study of Patients With AML

The first patient with acute myeloid leukemia (AML) in a phase 2 trial of the MultiTAA-specific T cell, MT-401 followed stem-cell transplant has been dosed with the agent, according to a press release by Marker Therapeutics, Inc.¹

MT-401 is a multicenter, phase 2 trial with a planned total enrollment of 160 patients. Of those patients, 120 patients will be in the adjuvant disease cohort. This group will be randomized 1:1 to receive either MT-401 90 days post allogeneic stem cell transplant or the standard of care, which is observation. The remaining 40 patients will be in the active disease cohort as part of the single arm. For the adjuvant disease group, the primary objective is relapsed-free survival and for the active disease group it’s complete response and duration of complete response.

The study is actively enrolling patients who meet the eligibility criteria. In order to enroll, patients must be 18 years of age or older and are undergoing or have relapsed after their first allogeneic HSCT for AML. Patients can enroll prior to their first allogeneic HSCT or are experiencing their first relapse after transplant. All patients are required have a Karnofsky/Lansky score of at least 60, a life expectancy of ≥12 weeks, as well as adequate blood, liver, and renal function. The study excludes patients who are have clinically significant or severely symptomatic intercurrent infection, are, pregnant or lactating, and those who showed evidence of chronic graft-versus-host-disease.²

The FDA granted Orphan Drug designation to MT-401 in April of 2020.3 Additionally, In January, the agency lifted a partial clinical hold that was placed on the phase 2 study of MT-401.

"We are pleased to have dosed the first patient with MT-401 in our Company-sponsored clinical trial, particularly in a patient population in which there remains a critical unmet need," said Mythili Koneru, MD, PhD, chief medical officer, Marker Therapeutics in a press release.¹ "Today, adult patients with post-transplant AML have a 25 percent chance of 5-year survival. In various investigator-sponsored Phase 1 trials at the Baylor College of Medicine, our MultiTAA-specific T cell therapies have been generally well-tolerated and demonstrated durable anti-cancer responses across a broad range of cancers—including post-transplant AML. Based on these results, we believe that MT-401 has the potential to become a meaningful treatment option for patients suffering from this disease."

A topline readout of the active disease group is expected in the first quarter of 2022.

^REFERENCE:

1. ^{Marker Therapeutics announces dosing of first patient in phase 2 trial of MT-401 in acute myeloid leukemia following stem cell transplant. News Release. March 3, 2021. Accessed March 3, 2021. https://www.markertherapeutics.com/2021/03/marker-therapeutics-announces-dosing-of-first-patient-in-phase-2-trial-of-mt-401-in-acute-myeloid-leukemia-following-stem-cell-transplant/}

2. ^{Efficacy of MT-401 in patients with AML following stem cell transplant. August 13, 2020; Accessed March 3, 2021. https://clinicaltrials.gov/ct2/show/NCT04511130?term=MT-401&draw=2&rank=1.}

3. ^{Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Acute Myeloid Leukemia News Release. April 29, 2020; Accessed March 3, 2021. https://www.markertherapeutics.com/2020/04/marker-therapeutics-receives-fda-orphan-drug-designation-for-its-multi-antigen-targeted-t-cell-therapy-for-acute-myeloid-leukemia}