Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581198
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
A Study of Rapcabtagene Autoleucel in Systemic Lupus Erythematosus SLE Patients With Active Refractory Lupus Nephritis LN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Adaptive Randomized Open-label Assessor-blinded Active-controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Standard of Care in Patients Suffering From Systemic Lupus Erythematosus SLE With Active Refractory Lupus Nephritis LN
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:
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel administered once following lymphodepletion versus Standard of Care SOC in patients with systemic lupus erythematosus SLE with active refractory lupus nephritis LN
Detailed Description:
This is a Phase 2 adaptive two-year randomized assessor-blinded active controlled study
Part A Participants suffering from systemic lupus erythematosus SLE with active refractory LN will be randomized to Regimen 1 Regimen 2 or SOC
Part B Participants suffering from SLE with active refractory LN will be randomized to the selected regimen from Part A or SOC
The study will consist of two periods
A screening period lasting up to 6 weeks and
A randomized treatment period and primary follow-up period lasting up to 104 weeks
After end of study EOS participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up LTFU period lasting up to 15 years after rapcabtagene autoleucel infusion This LTFU will be described in a separate study protocol
Part A Participants suffering from systemic lupus erythematosus SLE with active refractory LN will be randomized to Regimen 1 Regimen 2 or SOC
Part B Participants suffering from SLE with active refractory LN will be randomized to the selected regimen from Part A or SOC
The study will consist of two periods
A screening period lasting up to 6 weeks and
A randomized treatment period and primary follow-up period lasting up to 104 weeks
After end of study EOS participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up LTFU period lasting up to 15 years after rapcabtagene autoleucel infusion This LTFU will be described in a separate study protocol
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