Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 13, 2020

Primary Completion Date

November 30, 2022

Study Completion Date

November 30, 2023

Conditions
Acute Myeloid Leukemia (AML)Myelodysplastic Syndromes (MDS)
Interventions
BIOLOGICAL

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."

PROCEDURE

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."

PROCEDURE

HaploBMT

Bone marrow is the only allowed graft source for patients enrolled in this clinical trial

Trial Locations (2)

30432GA

Northside Hospital, Atlanta

77030TX

MD Anderson, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Kiadis Pharma

INDUSTRY

NCT04395092 - Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) | Biotech Hunter | Biotech Hunter