NCT04395092

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kiadis Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myeloid Leukemia (AML)
• Myelodysplastic Syndromes (MDS)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-13
• Primary completion: 2022-11-01
• Completion: 2023-11-01
• First posted: 2020-05-20
• Last updated: 2021-06-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study