Donor Enriched Activated NK (DEA-NK) Cell Infusion Post Haploidentical Stem Cell Transplant for Refractory Myeloid Malignancies - Trial NCT05375253

Timeline & Enrollment

Primary Outcome

Percent of successful DEA-NK cell infusions,Number of adverse events for those who have a DEA-NK cell infusion,Maximum tolerated dose of DEA-NK cell infusions

Summary

Patients with relapse refractory myeloid malignancies [acute myeloid leukemia (AML)
 myelodysplastic(MDS)/myeloproliferative(MPD) disorders] have no therapeutic options for long
 term remission. Haploidentical cytokine activated (IL-12, IL-18, IL-15) natural killer (NK)
 cell immunotherapy has been used with some success in treating patients with refractory
 relapsed AML. One limiting factor to the in-vivo expansion of infused activated NK cells is
 the recovery of recipient's immune system rejecting the infused NK cells. The use of
 haploidentical activated NK cell therapy post haploidentical transplant is an attractive
 option to induce in-vivo persistence of the infused NK cells and support anti leukemic
 efficacy.
 
 This is a pilot phase Ib trial testing the feasibility, safety and immunologic effects of
 dose escalated donor enriched (αβ-TCR+/CD19+ double depleted mononuclear cells) activated
 natural killer cell infusion (DEA-NK) on day +7 post haploidentical stem cell transplantation
 (Haplo-Tx) with post-transplant cyclophosphamide (PTCY). Inclusion criteria include: adult
 patient with relapse refractory AML, MDS, or MPD, available haploidentical related donor, and
 adequate organ functions to undergo reduced intensity allogenic stem cell transplant. The
 clinical trial will enroll 12-18 subjects in a 3+3 phase I dose escalation fashion over 24
 months. Subjects will be followed for 6 months and 1 year following Haplo-Tx.

ICD-10 Classifications