Marker Therapeutics has treated the first patient in its Phase II trial of its lead MultiTAA-specific T cell product candidate MT-401 in patients with acute myeloid leukaemia (AML).
The multi-center trial will have 160 patients with AML following an allogeneic stem cell transplant in both the adjuvant, as well as active disease settings.
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In the trial, 120 patients will be enrolled in the adjuvant disease group who are randomised into a 1:1 ratio to either receive MT-401 at 90 days post-transplant or standard of care (observation).
About 40 subjects with active disease will be given MT-401 as part of the single-arm group.
Marker noted that the trial will be carried out at 20 top cancer centres across the US.
Analysis of relapse-free survival (RFS) in the adjuvant arm and determining complete remission rate and duration of complete remission in active disease patients will form the trial’s primary objectives.
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By GlobalDataFor the adjuvant arm, overall survival and graft-versus-host disease relapse-free survival will be the additional objectives while overall response rate, duration of response, progression-free survival and overall survival will be included as the additional objectives for the active disease group.
Marker Therapeutics chief medical officer Mythili Koneru said: “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.
“In various investigator-sponsored Phase I 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.”
Topline data readout of active disease group is anticipated in the first quarter of next year.
