FDA Lifts Partial Hold on Trial Assessing Novel Therapy for Post-Transplant Acute Myeloid Leukemia


The FDA has lifted a partial clinical hold on a phase 2 trial evaluating a novel therapy in patients with acute myeloid leukemia following an allogenic stem cell transplant.

Marker Therapeutics announced that the Food and Drug Administration (FDA) lifted a partial clinical hold on a multicenter phase 2 trial to evaluate the safety and efficacy of a multi-tumor-associated antigen-specific T cell product candidate, MT-401, to treat patients with acute myeloid leukemia following an allogeneic stem cell transplant.

“We are pleased to move forward with our phase 2 AML trial of MT-401, which we believe may provide a safe and effective treatment option for patients with post-transplant AML over the standard of care," said Marker Therapeutics’ chief medical officer Dr. Mythili Koneru in a company-issued press release. “During the partial clinical hold, we continued to open clinical centers to enroll patients in the first half of the safety lead-in of our phase 2 trial. With the FDA's decision, we will now be able to seamlessly enroll patients in the second half of the safety lead-in, as well as the remainder of the trial. We look forward to working with our clinical sites to continue enrolling patients.”

The trial was designed to evaluate the safety and effectiveness of MT-401 in those with AML after an allogeneic stem-cell transplant. Approximately 120 patients in the adjuvant setting are expected to be randomized in a 1:1 fashion to receive either study drug at 90 days post-transplant or the standard-of-care observation. The second phase of the study is expected to include 40 patients with active disease, and they will receive the study drug.

Measuring relapse-free survival in the group in the adjuvant setting and determining complete remission rates and length of complete remission in patients with active disease are the main goals of the study.

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