Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)
This study is a Phase II, single arm, open label multicenter trial designed to investigate the use of haploidentical donor derived NK cells (K-NK002) for the treatment of patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are undergoing haploidentical donor bone marrow transplantation (HaploBMT). K-NK002 is a NK cell product derived from peripheral blood leukocytes collected from a related donor (HLA-haploidentical matched) and enriched for NK cells with depletion of CD3+ T-lymphocytes (T-cells) followed by enriched ex-vivo expansion and administered to the patient prior to and following BMT.
The study is a Phase II, single arm, open label, multicenter trial evaluating the cumulative incidence of relapse when K-NK002 is used for relapse mitigation in patients with high-risk AML and MDS receiving an allogeneic haploidentical bone marrow graft. Part One (Safety run-in): An initial safety run-in to confirm the starting dose, and safety and tolerability of K-NK002; - Dose cohort 1 will include 3 patients who will receive a dose of K-NK002 at 1 x 10E7 NK cells per kg. - Dose cohort 2 will include 3 patients who will receive K-NK002 at 1 x 10E8 NK cells per kg. Part Two (Open Enrollment): Enrollment into the second part of the study (Open Enrollment) can begin following Part One, confirmation of dose and safety. ;
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