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Clinical Trial Summary

The goal of this clinical research study is to learn about the safety and effectiveness of giving KDS-1001 in combination with a standard stem cell transplant to patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML). KDS-1001 is a study product created using certain immune cells called natural killer (NK) cells collected from a third-party donor.


Clinical Trial Description

Primary Objective Assess the safety and effectiveness of "off the shelf" third party NK cells in combination with allogeneic SCT in patients with myeloid malignancies. Secondary Objectives To assess NK cell related toxicities To estimate the proportion of patients with engraftment/graft failure. To assess the rate of leukemia relapse, disease-free survival (DFS), overall survival (OS), and GVHD-free, Relapse-free survival (GRFS) after transplantation by one year. To estimate the non-relapse mortality (NRM) at day 100, day 180 and 1 year post-transplant. To estimate the cumulative incidence of grade 2-4 and grades 3-4 aGVHD at day 100. To assess the rate of chronic GVHD within the first-year post transplantation. To assess rate of BK, CMV, and Adenovirus infections. To assess MRD. To assess immune reconstitution post-transplant ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05115630
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Jeremy Ramdial, MD
Phone (713) 745-0146
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date December 1, 2021
Completion date June 1, 2024

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