Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04623944
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2020-09-25
Brief Title:
NKX101 Intravenous Allogeneic CAR NK Cells in Adults With AML or MDS
Sponsor:
Nkarta Inc
Organization:
Nkarta Inc
Study Overview
Official Title:
A Phase 1 Study of NKX101 an Activating Chimeric Receptor Natural Killer Cell Therapy in Subjects With Hematological Malignancies or Dysplasias
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm open-label multi-center Phase 1 study to determine safety and tolerability of an experimental therapy called NKX101 allogeneic CAR NK cells targeting NKG2D ligands in patients with relapsedrefractory AML or intermediate high and very high risk relapsedrefractory MDS
Detailed Description:
This is a dose-finding study of NKX101 and will be conducted in 2 parts
Part 1 dose finding with two dosing regimens utilizing modified 33 enrollment schema
Part 2 dose expansion to further evaluate safety and tolerability cellular kinetics pharmacodynamics and anti-tumor response in expansion cohorts of patients with either AML or MDS
Part 1 dose finding with two dosing regimens utilizing modified 33 enrollment schema
Part 2 dose expansion to further evaluate safety and tolerability cellular kinetics pharmacodynamics and anti-tumor response in expansion cohorts of patients with either AML or MDS
Study Oversight
Has Oversight DMC:
None
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?:
None