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# FDA Clinical Hold on Marker Leukemia Trial
- URL: https://www.fdaweb.com/fda-clinical-hold-on-marker-leukemia-trial/
- Published: 2019-11-13T12:00:00.000Z
- Updated: 2026-09-14T15:53:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145497

FDA has placed a clinical hold on a Marker Therapeutics planned Phase 2 study of its MultiTAA T-cell therapy in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia in both the adjuvant and active disease setting. The company says the agency “reviewed our submission and requested additional information regarding certain quality and technical specifications for two reagents supplied by third party vendors that are used in our manufacturing process.”

Marker says that while the questioned reagents are not present in the final product, it worked with the manufacturers of the reagents to satisfy FDA’s questions and a complete response on the hold was filed late last month. It plans to begin the Phase 2 trial next year.

Additionally, the company says it will be discontinuing the development of TPIV200 in patients with platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results from its Phase 2 study. While its data and safety monitoring board did not cite any safety concerns, Marker says it has decided to suspend the trial because it “did not meet the threshold for probability of success based upon the company’s pre-specified criteria.”