Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518668
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
A Study of NKX019 a CD19 CAR NK Cell Therapy in Subjects With Systemic Lupus Erythematosus
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 Systemic Lupus Erythematosus
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Primary objective Safety and tolerability of NKX019 administered after lymphodepletion LD
Secondary objectives
Assess clinical activity of NKX019 in subjects with systemic lupus erythematosus SLE with or without active lupus nephritis LN
Characterize pharmacokinetics PK of NKX019
Characterize immunogenicity of NKX019
Secondary objectives
Assess clinical activity of NKX019 in subjects with systemic lupus erythematosus SLE with or without active lupus nephritis LN
Characterize pharmacokinetics PK of NKX019
Characterize immunogenicity of NKX019
Detailed Description:
This is an open-label non-randomized Phase 1 study Subjects with SLE will receive cyclophosphamide LD followed by NKX019 to determine safety and preliminary efficacy
The study will consist of 4 study periods for each study subject inclusive of Screening Active Treatment Follow-up and Extended Follow-up Disease assessments will occur every 90 days for 2 years
The study will consist of 4 study periods for each study subject inclusive of Screening Active Treatment Follow-up and Extended Follow-up Disease assessments will occur every 90 days for 2 years
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