Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557265
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
NKX019 Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells CAR NK in Adults With Autoimmune Disease Ntrust-1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study of NKX019 a CD19 Chimeric Antigen Receptor Natural Killer CAR NK Cell Therapy in Subjects With Autoimmune Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multi-center non-randomized Phase 1 study to determine the safety and tolerability of NKX019 allogeneic CAR NK cells targeting CD19 in participants with active lupus nephritis LN
Detailed Description:
This is a dose-finding study of NKX019 and will be conducted in 2 parts
Part 1 dose escalation will utilize a 33 design to determine the recommended dose for expansion for Part 2 The study will evaluate safety and tolerability preliminary activity cellular kinetics pharmacodynamics in participants with active LN Participants will receive three-dose cycle of NKX019 following single-agent lymphodepletion with cyclophosphamide
Part 1 dose escalation will utilize a 33 design to determine the recommended dose for expansion for Part 2 The study will evaluate safety and tolerability preliminary activity cellular kinetics pharmacodynamics in participants with active LN Participants will receive three-dose cycle of NKX019 following single-agent lymphodepletion with cyclophosphamide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None