Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05020678
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2021-08-20
Brief Title:
NKX019 Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells CAR NK in Adults With B-cell Cancers
Sponsor:
Nkarta Inc
Organization:
Nkarta Inc
Study Overview
Official Title:
A Phase 1 Study of NKX019 a CD19 Chimeric Antigen Receptor Natural Killer CAR NK Cell Therapy in Subjects With B-cell Malignancies
Status:
RECRUITING
Status Verified Date:
2024-03
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 the safety and tolerability of an experimental therapy called NKX019 allogeneic CAR NK cells targeting CD19 in patients with relapsedrefractory non-Hodgkin lymphoma NHL chronic lymphocytic leukemia CLL or B cell acute lymphoblastic leukemia B-ALL
Detailed Description:
This is a dose-finding study of NKX019 and will be conducted in 2 parts
Part 1 dose finding utilizing a 33 enrollment schema and safety lead-in to confirm dose for NKX019 in combination with rituximab expansion cohorts as applicable Part 2 dose expansion to further evaluate safety and tolerability cellular kinetics pharmacodynamics and anti-tumor response in expansion cohorts of patients with large B cell lymphoma LBCL mantle cell lymphoma MCL indolent lymphoma IL Waldenström macroglobulinemia WM CLL small lymphocytic lymphoma SLL and B-ALL
Part 1 dose finding utilizing a 33 enrollment schema and safety lead-in to confirm dose for NKX019 in combination with rituximab expansion cohorts as applicable Part 2 dose expansion to further evaluate safety and tolerability cellular kinetics pharmacodynamics and anti-tumor response in expansion cohorts of patients with large B cell lymphoma LBCL mantle cell lymphoma MCL indolent lymphoma IL Waldenström macroglobulinemia WM CLL small lymphocytic lymphoma SLL and B-ALL
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