Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
Study NCT ID:
NCT04395092
Status:
WITHDRAWN
Last Update Posted:
2021-06-22
First Post:
2020-05-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)
Sponsor:
Kiadis Pharma
Organization:
Study Overview
Official Title:
Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor decided to withdraw this study
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U24HL138660 | NIH | None | https://reporter.nih.gov/quic… | View |