Symptoms and General Pathology

All Conditions

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Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

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Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

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Myeloid Leukemia

Acute Myeloid Leukemia

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Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Melphalan

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.

K-NK002

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.

Conditioning Regimen

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

HaploBMT

Sumithira Vasu, MD

Richard Champlin, MD

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.

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

Cumulative incidence of relapse at 1 year

As assessed by CTCAE v5.0, incidence of AEs and serious adverse events (SAEs) will be collected from the 1st dose of K-NK002 through 30 days after the last dose. In addition, any SAEs assessed as related to the investigational product that occurs after the 30-day follow-up period will be recorded till end of study.

* Neutrophil recovery: absolute neutrophil count (ANC) ≥ 500/mm3 for three consecutive measurements on three different days.
* Platelet recovery: the first day of a sustained platelet count ≥ 20,000/mm3 or ≥50,000/mm3 with no platelet transfusions in the preceding seven days.

Frequencies and percentage of patients with full (\>95%), mixed (5-95%), or low (\<5%) chimerism at each time point. Mixed and full chimerism will be evidence of donor cell engraftment.

Incidence of all grade 1-5 AE from 1st dose of K-NK002 to 30 days after the last dose of K-NK002 according to CTCAE v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)	NCT04395092	Acute Myeloid L... Myelodysplastic...	K-NK002 Conditioning Re... HaploBMT	18 Years - 65 Years	Kiadis Pharma
Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)	NCT04395092	Acute Myeloid L... Myelodysplastic...	K-NK002 Conditioning Re... HaploBMT	18 Years - 65 Years	Kiadis Pharma

Spots Global Cancer Trial Database for haplobmt

Every month we try and update this database with for haplobmt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for haplobmt

Every month we try and update this database with for haplobmt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for haplobmt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.