Start Date
November 13, 2020
Primary Completion Date
November 30, 2022
Study Completion Date
November 30, 2023
K-NK002
"K-NK002 will be administered intravenous (IV) on Day -2, Day +7 and Day +28.~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."
Conditioning Regimen
"From Day -7 to Day -3:~* Melphalan: 140 mg/m2 (100mg/m2 in patients ≥ 60) on Day -7.~* Fludarabine: 40 mg/m2 daily for 4 doses starting on days -7.~* TBI: 2 Gy on Day -3."
HaploBMT
Bone marrow is the only allowed graft source for patients enrolled in this clinical trial
Northside Hospital, Atlanta
MD Anderson, Houston
Lead Sponsor
Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
Kiadis Pharma
INDUSTRY