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

NCT04395092 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-06-22

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Blood and Marrow Transplant Clinical Trials Network

    collaborator NETWORK

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Kiadis Pharma

    lead INDUSTRY

Principal Investigators

  • Sumithira Vasu, MD · Ohio State University

  • Richard Champlin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2022-11-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04395092 on ClinicalTrials.gov